Maternal Care Patterns, Preterm Birth, Swallowing Disorder, Tube Feeding
Conditions
Keywords
Prematurity, sensory-motor stimulation, oral feed establishment, feeding intervention
Brief summary
Hypothesis Preterm babies who receive sensory motor stimulation from their mothers as compared to trained nurses will 1. Start taking oral feed at the same time as compared to control group 2. Take the same amount of milk at the commencement of oral feeding 3. Take milk with equal efficiency 4. Not face more adverse effects
Detailed description
Aim To determine the maternal role in sensory-motor stimulation for oral feed establishment in preterm neonates Objective 1. Determine the effect of sensory-motor stimulation offered by the mother on the onset of oral feeding 2. Efficiency of mother-mediated stimulation techniques on oral feeding as compared to trained nurses 3. Study maternal role in the establishment of oral feed Hypothesis Preterm babies who receive sensory motor stimulation from their mothers as compared to trained nurses will 1\. Start taking oral feed at the same time frame as compared to the control group 2. Take the very same amount of milk at the commencement of oral feeding 3. Take milk with equal efficiency 4. There is no extra burden of adverse effects Data Collection All on going and related trials for this intervention shall be registered in the ClinicalTrials.gov. Study shall be conducted after ethical approval from IRB. All participants shall be enrolled after written informed consent from mothers after approval from attending neonatologist (annexure 2). All relevant maternal and neonatal data shall be collected on a specially designed proforma (annexure 3) with following details 1. Part 1: Maternal demographic and clinical data (age, parity, educational qualification, residence, previous preterm baby, job status, diabetes, hypertensive disorders, chronic ailment, multifetal gestation 2. Part 2: Neonatal demographic data (gender, gestation age, birth weight, growth centiles, diagnosis, APGAR score, noninvasive (NIV) and invasive ventilation with duration, caffeine, days taken for establishment of gavage feeding, age, and weight at commencement of intervention, any other complication during study) 3. Part 3: Neonatal feeding physiological measurements (SpO2, respiratory rate, heart rate before and after feeding, daily weight gain, type of milk offered) 4. Part 4: Oral feeding skill (OFS) assessment adapted from the model presented by Lau and Smith (p). All parameters shall be recorded twice a day for D1, D2, and D3 separately. It includes * Total volume prescribed (ml) * Total volume has taken during feeding (ml) * Volume has taken during the first 5 min of feeding (ml) * Duration of oral feeding (min) * Overall transfer (OT %) volume taken/total volume prescribed * Proficiency(PRO%) volume taken during the first 5 min/total volume prescribed * Rate of transfer (RT) ml/min * SSB (Suck Swallow Breaths) coordination * Adverse events (cough, fatigue) * According to this oral feeding ability can be classified into four levels depending upon the level of maturity in ascending order as follows: * Level 1: PRO \< 30% and RT \< 1.5 ml/min * Level 2: PRO \< 30% and RT ≥ 1.5 ml/min * Level 3: PRO ≥ 30% and RT \< 1.5 ml/min * Level 4: PRO ≥ 30% and RT ≥ 1.5 ml/min
Interventions
OTHERperioral sensory motor stimulation
Step 1 - 6 over 5 minutes 1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek 2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek 3 Move index finger from one corner to opposite one over both lips separately 7x each lip 4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum 5 Move the finger from front to back on the hard palate while applying gentle pressure 7x 6 Displace the center of the tongue with gentle pressure 7x 7 Offer pacifier at the end 2 minutes Note: 7x means 7 times
Sponsors
Fatima Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Caregiver)
Masking description
The mothers, medical staff involved in general care, nursing staff involved in the intervention, and doctors conducting the assessment of oral feeding skills (OFS) were all blinded to allocation. The nursing staff was informed at the time of intervention that participating infants would receive either sensory motor stimulation or sham oral stimulation depending on group allocation.
Intervention model description
1. Maternal involvement in perioral sensory-motor stimulation be in three stages 1. Observer status 2. Performing under supervision 3. Independent 2. Intervention period: 5 days as 1. Training phase (T): T1 and T2 (for mothers by the nurse) 2. Direct feeding phase (D): F1, 2, and 3 (oral feed shall be offered to neonate) 3. Stimulation for 7 minutes and 15 minutes before feeding twice a day at 1100 and 1700 hrs. 4. Two groups 1. Intervention group (GI): by mothers 2. Control group (G II): by staff nurses
Eligibility
Sex/Gender
ALL
Age
30 Weeks to 34 Weeks
Healthy volunteers
Yes
Inclusion criteria
* All preterm of gestation age 28 to 34weeks * Haemodynamically stable * Established full Gavage feed * No respiratory distress * No need for respiratory support except LFNC * Do not receive any kind of analgesics
Exclusion criteria
* Syndromic babies /genetic disorders * Haemodynamically unstable babies including IVH (grade III & IV), hemodynamically significant PDA on treatment, NEC(stage III) * Major malformations * Cleft lip and palate * Anemia requiring blood transfusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transition Time to Full Oral Feeding | Expected time of oral feed establishment | Time interval between commencement of perioral sensory stimulation on D1 to establishment of full oral feed in both groups. It was done daily till 14th day of perioral sensory motor stimulation. Transition time to full oral feeding was the day at which baby was able to take oral feed of volume of 120-140ml/kg/day. |
| Improvement (Change) in Efficiency in Oral Feed Establishment | For record purpose in this study results, efficacy level was noted as L4 on the following days D1, D2, D3, D5, D7 and D14 | According to this efficiency in oral feed establishment in terms of amount and time is determined for the intervention group vs the control group. It can be classified into four levels depending upon the level of maturity in ascending order as follows: * Level 1: PRO \< 30% and RT \< 1.5 ml/min * Level 2: PRO \< 30% and RT ≥ 1.5 ml/min * Level 3: PRO ≥ 30% and RT \< 1.5 ml/min * Level 4: PRO ≥ 30% and RT ≥ 1.5 ml/min For all neonates, efficacy was measured at 11.00 am and 5.00 pm following sensory motor stimulation for both groups till achievement of full oral feed. |
| •Adverse Outcome Monitoring | Adverse events were noted on D1, D2,D3,D5,D7 and D14 | monitor for any adverse events like cough, breath holding, chocking, aspiration, tachycardia, and or bradycardia with 1. stimulation 2. feed Adverse outcome monitoring as non-life threatening adverse events including cough, tachycardia HR 180-200/min, bradycardia HR120 - 100/min, , tachypnea RR 60 - 70/min while maintaining SpO2 of \>90% at room air |
| •Adverse Events Monitoring | Adverse events were noted on D1, D2,D3,D5,D7 and D14 | monitor for any adverse events like cough, breath holding, chocking, aspiration, tachycardia, and or bradycardia with 1. stimulation 2. feed Adverse outcome monitoring as non-life threatening adverse events including cough, tachycardia HR 180-200/min, bradycardia HR120 - 100/min, , tachypnea RR 60 - 70/min while maintaining SpO2 of \>90% at room air |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| • Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed | PRO % was measured on D1, D2, D3, D5, D7 and D14 | how much amount of milk is taken during first 5 minutes while administering oral feeding |
| • Total Volume Taken During Each Feeding | It was noted on D1, D2, D3, D5, D7 and D14 | It is the measure of how much feed has been taken orally out of total feed prescribed for each feeding |
| • Neonates Feeding With SSB Coordination | It was measured on D1, D2, D3, D5, D7 and D14 | number of neonates who are feeding well and showing coordinated pattern of suck swallow and breath (SSB) |
| • Volume Taken During the First 5 Min of Feeding (ml) VT5 | Volume taken during the first 5 min of feeding (ml) VT5 was measured on D1, D2, D3, D5, D7 and D14 | during each feed taken orally by neonate VT5 is the amount of feed was taken by neonate during first 5 minutes |
| •Rate of Transfer (RT) ml/Min | RT was measured on D1, D2, D3, D5, D7 and D14 | RT is the time taken by neonate to finish oral feed |
| • Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed | OT was measured on D1, D2, D3, D5, D7 and D14 | trend towards oral feed establishment and is measured as overall transfer of milk yo oral out of total amount prescribed |
Countries
Pakistan
Participant flow
Recruitment details
The study period spans 16 months (March 2022 - July 2023), in the department of Neonatology, Fatima Memorial Hospital, Lahore. All preterm of gestation age 28 to 34 weeks, admitted to NICU during the study period after seeking consent from parents or guardians were enrolled. All neonates having major anomalies incompatible with life, cleft lip and palate, genetic disorders, IVH (grade III & IV), HsPDA, hemodynamic instability, NEC (stage II & III) or anemia requiring transfusion were excluded.
Pre-assignment details
Out of 142 eligible neonates, study was started with 130 as 65 in each group. Twelve neonates were excluded as 2 mothers experienced serious postnatal complications, 1 instance of parental refusal after initial participation, 1 case with incomplete data, and 8 others. Out of 65 neonates in each group, in 49 from intervention group and 48 from control group, sensory motor stimulation could be performed per protocol as 33 total neonates were excluded and details have been mentioned in table.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group (Group 1) Maternal involvement was done in three stages for the intervention group as
* Observer status
* Performing under supervision
* Independent
* Study groups for sensory motor stimulation (5 minutes) + pacifier (2 minutes) Intervention group (Group I): by mothers
1. T1: Nurses performed all steps while mother observer status
2. T2: Nurses performed all steps in front of the mother and a pacifier was offered by the mother
3. D1: Mother performed all steps and oral milk was offered by the nurse while the mother observed.
4. D2: Mother performed all steps and offering oral milk under nurse supervision
5. D3: Mother performed all steps independently perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
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1. With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek
2. While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek
3. Move index finger from one corner to opposite one over both lips separately 7x each lip
4. Gentle massage and compress the gums from center to back of mouth 7x each half of the gum
5. Move the finger from front to back on the hard palate while applying gentle pressure 7x
6. Displace the center of the tongue with gentle pressure 7x
7. Offer pacifier at the end 2 minutes Note: 7x means 7 times | 49 |
| Control Group (Group 2) All steps were the same as the intervention group and were performed by staff nurses perioral sensory motor stimulation: Step 1 - 6 over 5 minutes
1 With the help of the index finger, on the external surface of the cheek, make a circle starting from the angle of the mouth towards the ear then back 7x each cheek 2 While holding both sides of the cheek with help of the thumb and index finger repeat step 1 7x each cheek 3 Move index finger from one corner to opposite one over both lips separately 7x each lip 4 Gentle massage and compress the gums from center to back of mouth 7x each half of the gum 5 Move the finger from front to back on the hard palate while applying gentle pressure 7x 6 Displace the center of the tongue with gentle pressure 7x 7 Offer pacifier at the end 2 minutes Note: 7x means 7 times | 48 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | continued need of mechanical ventilation | 2 | 3 |
| Overall Study | failure to establish gavage feed by 2 weeks of chronological age | 4 | 2 |
| Overall Study | HsPDA requiring antifailure therapy | 1 | 2 |
| Overall Study | IVH (G III & IV) | 2 | 1 |
| Overall Study | NEC (stage II & III) | 2 | 3 |
| Overall Study | Protocol Violation | 3 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Control Group (Group 2) | Total | Intervention Group (Group 1) |
|---|---|---|---|
| Age, Continuous | 30 years | 29.5 years | 29 years |
| anemia of pregnancy | 21 Participants | 46 Participants | 25 Participants |
| Apnea | 20 Participants | 38 Participants | 18 Participants |
| Birth weight | 1.34 Kg | 1.31 Kg | 1.29 Kg |
| Caffeine | 28 Participants | 56 Participants | 28 Participants |
| Chronological age (ChA) at enrollment | 9 days | 11 days | 13 days |
| Discharge weight | 1.48 Kg | 1.48 Kg | 1.48 Kg |
| Duration of IMV | 2 days | 1.5 days | 1 days |
| Duration of LFNC | 3.5 days | 3.75 days | 4 days |
| Duration of non invasive ventilation (NIV) | 4 days | 3.5 days | 3 days |
| Duration of stay in NICU | 30 days | 25.5 days | 21 days |
| Feeding intolerence | 25 Participants | 45 Participants | 20 Participants |
| Gestation age at delivery | 31 weeks | 30.5 weeks | 30 weeks |
| Gestational diabetes mellitus | 17 Participants | 34 Participants | 17 Participants |
| Gravidity 2 - 3 | 15 Participants | 37 Participants | 22 Participants |
| Gravidity 4 or more | 7 Participants | 14 Participants | 7 Participants |
| Gravidity Primigravida (PG) | 26 Participants | 46 Participants | 20 Participants |
| Hemodynamically significant patent ductus arteriosus (HsPDA) | 20 Participants | 37 Participants | 17 Participants |
| hypertensive disorder of pregnancy | 32 Participants | 61 Participants | 29 Participants |
| Maternal education Higher | 16 Participants | 37 Participants | 21 Participants |
| Maternal education Primary | 10 Participants | 21 Participants | 11 Participants |
| Maternal education Secondary | 20 Participants | 35 Participants | 15 Participants |
| Maternal education Uneducated | 2 Participants | 4 Participants | 2 Participants |
| Maternal Job status home maker | 31 Participants | 60 Participants | 29 Participants |
| Maternal Job status job doing | 17 Participants | 37 Participants | 20 Participants |
| Mode of delivery (SVD) | 29 Participants | 55 Participants | 26 Participants |
| mothers with previous preterm neonates | 38 Participants | 80 Participants | 42 Participants |
| Necrotizing enterocolitis (NEC) | 12 Participants | 21 Participants | 9 Participants |
| neonatal gender (male) | 22 Participants | 49 Participants | 27 Participants |
| Place of birth (Inborn) | 33 Participants | 63 Participants | 30 Participants |
| Post menstural age (PMA) at enrollment | 32 weeks | 32 weeks | 32 weeks |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Required Invasive mechanical ventilation (IMV) | 30 Participants | 56 Participants | 26 Participants |
| Required low flow nasal cannula therapy (LFNC) | 43 Participants | 90 Participants | 47 Participants |
| Required non invasive ventilation (NIV) | 48 Participants | 93 Participants | 45 Participants |
| Respiratory distress syndrome (RDS) | 25 Participants | 50 Participants | 25 Participants |
| Seizures | 5 Participants | 12 Participants | 7 Participants |
| Sepsis | 41 Participants | 84 Participants | 43 Participants |
| Sex/Gender, Customized | 48 Participants | 97 Participants | 49 Participants |
| Time to full gavage feed | 7 days | 7 days | 7 days |
| Weight at enrollment | 1.35 Kg | 1.35 Kg | 1.35 Kg |
| Weight for gestational age Appropriate for gestation age (AGA) | 30 Participants | 57 Participants | 27 Participants |
| Weight for gestational age Large for gestation age (LGA) | 3 Participants | 9 Participants | 6 Participants |
| Weight for gestational age Small for gestation age (SGA) | 15 Participants | 31 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 48 |
| other Total, other adverse events | 16 / 49 | 19 / 48 |
| serious Total, serious adverse events | 0 / 49 | 0 / 48 |
Outcome results
Primary
•Adverse Events Monitoring
monitor for any adverse events like cough, breath holding, chocking, aspiration, tachycardia, and or bradycardia with 1. stimulation 2. feed Adverse outcome monitoring as non-life threatening adverse events including cough, tachycardia HR 180-200/min, bradycardia HR120 - 100/min, , tachypnea RR 60 - 70/min while maintaining SpO2 of \>90% at room air
Time frame: Adverse events were noted on D1, D2,D3,D5,D7 and D14
Population: All neonates were monitored for adverse outcome. This monitoring was done as non-life threatening adverse events including cough, tachycardia HR 180-200/min, bradycardia HR120 - 100/min, , tachypnea RR 60 - 70/min while maintaining SpO2 of \>90% at room air
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group (Group 1) | •Adverse Events Monitoring | Adverse events D2 | 14 Participants |
| Intervention Group (Group 1) | •Adverse Events Monitoring | Averse events D5 | 0 Participants |
| Intervention Group (Group 1) | •Adverse Events Monitoring | Adverse events D3 | 12 Participants |
| Intervention Group (Group 1) | •Adverse Events Monitoring | Adverse events D7 & 14 | 0 Participants |
| Intervention Group (Group 1) | •Adverse Events Monitoring | Adverse events D1 | 31 Participants |
| Control Group (Group 2) | •Adverse Events Monitoring | Adverse events D7 & 14 | 0 Participants |
| Control Group (Group 2) | •Adverse Events Monitoring | Adverse events D1 | 36 Participants |
| Control Group (Group 2) | •Adverse Events Monitoring | Adverse events D2 | 14 Participants |
| Control Group (Group 2) | •Adverse Events Monitoring | Adverse events D3 | 12 Participants |
| Control Group (Group 2) | •Adverse Events Monitoring | Averse events D5 | 2 Participants |
Primary
•Adverse Outcome Monitoring
monitor for any adverse events like cough, breath holding, chocking, aspiration, tachycardia, and or bradycardia with 1. stimulation 2. feed Adverse outcome monitoring as non-life threatening adverse events including cough, tachycardia HR 180-200/min, bradycardia HR120 - 100/min, , tachypnea RR 60 - 70/min while maintaining SpO2 of \>90% at room air
Time frame: Adverse events were noted on D1, D2,D3,D5,D7 and D14
Population: All neonates were monitored for adverse outcome. This monitoring was done as non-life threatening adverse events including cough, tachycardia HR 180-200/min, bradycardia HR120 - 100/min, , tachypnea RR 60 - 70/min while maintaining SpO2 of \>90% at room air
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group (Group 1) | •Adverse Outcome Monitoring | Adverse events D2 | 14 Participants |
| Intervention Group (Group 1) | •Adverse Outcome Monitoring | Averse events D5 | 0 Participants |
| Intervention Group (Group 1) | •Adverse Outcome Monitoring | Adverse events D3 | 12 Participants |
| Intervention Group (Group 1) | •Adverse Outcome Monitoring | Adverse events D7 & 14 | 0 Participants |
| Intervention Group (Group 1) | •Adverse Outcome Monitoring | Adverse events D1 | 31 Participants |
| Control Group (Group 2) | •Adverse Outcome Monitoring | Adverse events D7 & 14 | 0 Participants |
| Control Group (Group 2) | •Adverse Outcome Monitoring | Adverse events D1 | 36 Participants |
| Control Group (Group 2) | •Adverse Outcome Monitoring | Adverse events D2 | 14 Participants |
| Control Group (Group 2) | •Adverse Outcome Monitoring | Adverse events D3 | 12 Participants |
| Control Group (Group 2) | •Adverse Outcome Monitoring | Averse events D5 | 2 Participants |
Primary
Improvement (Change) in Efficiency in Oral Feed Establishment
According to this efficiency in oral feed establishment in terms of amount and time is determined for the intervention group vs the control group. It can be classified into four levels depending upon the level of maturity in ascending order as follows: * Level 1: PRO \< 30% and RT \< 1.5 ml/min * Level 2: PRO \< 30% and RT ≥ 1.5 ml/min * Level 3: PRO ≥ 30% and RT \< 1.5 ml/min * Level 4: PRO ≥ 30% and RT ≥ 1.5 ml/min For all neonates, efficacy was measured at 11.00 am and 5.00 pm following sensory motor stimulation for both groups till achievement of full oral feed.
Time frame: For record purpose in this study results, efficacy level was noted as L4 on the following days D1, D2, D3, D5, D7 and D14
Population: neonates were assessed for efficacy of level 4 (L4) on D1, D2,D3,D5,D7 and D14
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group (Group 1) | Improvement (Change) in Efficiency in Oral Feed Establishment | L4 efficacy by D7 | 15 Participants |
| Intervention Group (Group 1) | Improvement (Change) in Efficiency in Oral Feed Establishment | L4 efficacy by D5 | 9 Participants |
| Intervention Group (Group 1) | Improvement (Change) in Efficiency in Oral Feed Establishment | L4 efficacy by D14 | 36 Participants |
| Intervention Group (Group 1) | Improvement (Change) in Efficiency in Oral Feed Establishment | L4 efficacy by D1-3 | 0 Participants |
| Control Group (Group 2) | Improvement (Change) in Efficiency in Oral Feed Establishment | L4 efficacy by D14 | 35 Participants |
| Control Group (Group 2) | Improvement (Change) in Efficiency in Oral Feed Establishment | L4 efficacy by D1-3 | 0 Participants |
| Control Group (Group 2) | Improvement (Change) in Efficiency in Oral Feed Establishment | L4 efficacy by D5 | 12 Participants |
| Control Group (Group 2) | Improvement (Change) in Efficiency in Oral Feed Establishment | L4 efficacy by D7 | 16 Participants |
Primary
Transition Time to Full Oral Feeding
Time interval between commencement of perioral sensory stimulation on D1 to establishment of full oral feed in both groups. It was done daily till 14th day of perioral sensory motor stimulation. Transition time to full oral feeding was the day at which baby was able to take oral feed of volume of 120-140ml/kg/day.
Time frame: Expected time of oral feed establishment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group (Group 1) | Transition Time to Full Oral Feeding | 10 days |
| Control Group (Group 2) | Transition Time to Full Oral Feeding | 9 days |
Secondary
• Neonates Feeding With SSB Coordination
number of neonates who are feeding well and showing coordinated pattern of suck swallow and breath (SSB)
Time frame: It was measured on D1, D2, D3, D5, D7 and D14
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention Group (Group 1) | • Neonates Feeding With SSB Coordination | SSB on D1 | 23 Participants |
| Intervention Group (Group 1) | • Neonates Feeding With SSB Coordination | SSB on D3 | 32 Participants |
| Intervention Group (Group 1) | • Neonates Feeding With SSB Coordination | SSB on D5 | 37 Participants |
| Intervention Group (Group 1) | • Neonates Feeding With SSB Coordination | SSB on D7 | 36 Participants |
| Intervention Group (Group 1) | • Neonates Feeding With SSB Coordination | SSB on D14 | 48 Participants |
| Intervention Group (Group 1) | • Neonates Feeding With SSB Coordination | SSB on D2 | 27 Participants |
| Control Group (Group 2) | • Neonates Feeding With SSB Coordination | SSB on D14 | 49 Participants |
| Control Group (Group 2) | • Neonates Feeding With SSB Coordination | SSB on D2 | 33 Participants |
| Control Group (Group 2) | • Neonates Feeding With SSB Coordination | SSB on D7 | 39 Participants |
| Control Group (Group 2) | • Neonates Feeding With SSB Coordination | SSB on D3 | 33 Participants |
| Control Group (Group 2) | • Neonates Feeding With SSB Coordination | SSB on D1 | 22 Participants |
| Control Group (Group 2) | • Neonates Feeding With SSB Coordination | SSB on D5 | 40 Participants |
Secondary
• Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed
trend towards oral feed establishment and is measured as overall transfer of milk yo oral out of total amount prescribed
Time frame: OT was measured on D1, D2, D3, D5, D7 and D14
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group (Group 1) | • Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed | OT on D14 | 95.5 percentage of volume taken/total volume |
| Intervention Group (Group 1) | • Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed | OT on D2 | 35.7 percentage of volume taken/total volume |
| Intervention Group (Group 1) | • Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed | OT on D3 | 43.8 percentage of volume taken/total volume |
| Intervention Group (Group 1) | • Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed | OT on D5 | 48 percentage of volume taken/total volume |
| Intervention Group (Group 1) | • Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed | OT on D7 | 56 percentage of volume taken/total volume |
| Intervention Group (Group 1) | • Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed | OT on D1 | 21 percentage of volume taken/total volume |
| Control Group (Group 2) | • Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed | OT on D7 | 60 percentage of volume taken/total volume |
| Control Group (Group 2) | • Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed | OT on D1 | 21 percentage of volume taken/total volume |
| Control Group (Group 2) | • Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed | OT on D14 | 91 percentage of volume taken/total volume |
| Control Group (Group 2) | • Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed | OT on D2 | 36 percentage of volume taken/total volume |
| Control Group (Group 2) | • Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed | OT on D5 | 48 percentage of volume taken/total volume |
| Control Group (Group 2) | • Overall Transfer (OT Percent) Volume Taken/Total Volume Prescribed | OT on D3 | 43.8 percentage of volume taken/total volume |
Secondary
• Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed
how much amount of milk is taken during first 5 minutes while administering oral feeding
Time frame: PRO % was measured on D1, D2, D3, D5, D7 and D14
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group (Group 1) | • Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed | PRO on D1 | 16 percentage of volume taken during the fi |
| Intervention Group (Group 1) | • Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed | PRO on D2 | 21 percentage of volume taken during the fi |
| Intervention Group (Group 1) | • Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed | PRO on D3 | 19.5 percentage of volume taken during the fi |
| Intervention Group (Group 1) | • Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed | PRO on D5 | 29 percentage of volume taken during the fi |
| Intervention Group (Group 1) | • Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed | PRO on D7 | 39 percentage of volume taken during the fi |
| Intervention Group (Group 1) | • Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed | PRO on D14 | 55.8 percentage of volume taken during the fi |
| Control Group (Group 2) | • Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed | PRO on D7 | 39 percentage of volume taken during the fi |
| Control Group (Group 2) | • Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed | PRO on D1 | 16 percentage of volume taken during the fi |
| Control Group (Group 2) | • Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed | PRO on D5 | 30 percentage of volume taken during the fi |
| Control Group (Group 2) | • Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed | PRO on D2 | 21.6 percentage of volume taken during the fi |
| Control Group (Group 2) | • Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed | PRO on D14 | 56 percentage of volume taken during the fi |
| Control Group (Group 2) | • Proficiency(PRO Percent) Volume Taken During the First 5 Min/Total Volume Prescribed | PRO on D3 | 23 percentage of volume taken during the fi |
Secondary
•Rate of Transfer (RT) ml/Min
RT is the time taken by neonate to finish oral feed
Time frame: RT was measured on D1, D2, D3, D5, D7 and D14
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group (Group 1) | •Rate of Transfer (RT) ml/Min | RT on D1 | 0.42 ml/min |
| Intervention Group (Group 1) | •Rate of Transfer (RT) ml/Min | RT on D3 | 0.70 ml/min |
| Intervention Group (Group 1) | •Rate of Transfer (RT) ml/Min | RT on D5 | 0.90 ml/min |
| Intervention Group (Group 1) | •Rate of Transfer (RT) ml/Min | RT on D2 | 0.71 ml/min |
| Intervention Group (Group 1) | •Rate of Transfer (RT) ml/Min | RT on D14 | 1.6 ml/min |
| Intervention Group (Group 1) | •Rate of Transfer (RT) ml/Min | RT on D7 | 1.0 ml/min |
| Control Group (Group 2) | •Rate of Transfer (RT) ml/Min | RT on D14 | 1.6 ml/min |
| Control Group (Group 2) | •Rate of Transfer (RT) ml/Min | RT on D5 | 0.83 ml/min |
| Control Group (Group 2) | •Rate of Transfer (RT) ml/Min | RT on D1 | 0.42 ml/min |
| Control Group (Group 2) | •Rate of Transfer (RT) ml/Min | RT on D2 | 0.70 ml/min |
| Control Group (Group 2) | •Rate of Transfer (RT) ml/Min | RT on D3 | 0.70 ml/min |
| Control Group (Group 2) | •Rate of Transfer (RT) ml/Min | RT on D7 | 1.0 ml/min |
Secondary
• Total Volume Taken During Each Feeding
It is the measure of how much feed has been taken orally out of total feed prescribed for each feeding
Time frame: It was noted on D1, D2, D3, D5, D7 and D14
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group (Group 1) | • Total Volume Taken During Each Feeding | Oral feed volume/feed on D5 | 6.5 ml |
| Intervention Group (Group 1) | • Total Volume Taken During Each Feeding | Oral feed volume/feed on D2 | 3 ml |
| Intervention Group (Group 1) | • Total Volume Taken During Each Feeding | Oral feed volume/feed on D3 | 4 ml |
| Intervention Group (Group 1) | • Total Volume Taken During Each Feeding | Oral feed volume/feed on D7 | 7.5 ml |
| Intervention Group (Group 1) | • Total Volume Taken During Each Feeding | Oral feed volume/feed on D14 | 15.5 ml |
| Intervention Group (Group 1) | • Total Volume Taken During Each Feeding | Oral feed volume/feed on D1 | 2 ml |
| Control Group (Group 2) | • Total Volume Taken During Each Feeding | Oral feed volume/feed on D14 | 15.5 ml |
| Control Group (Group 2) | • Total Volume Taken During Each Feeding | Oral feed volume/feed on D1 | 2 ml |
| Control Group (Group 2) | • Total Volume Taken During Each Feeding | Oral feed volume/feed on D7 | 9 ml |
| Control Group (Group 2) | • Total Volume Taken During Each Feeding | Oral feed volume/feed on D2 | 5 ml |
| Control Group (Group 2) | • Total Volume Taken During Each Feeding | Oral feed volume/feed on D3 | 7 ml |
| Control Group (Group 2) | • Total Volume Taken During Each Feeding | Oral feed volume/feed on D5 | 8 ml |
Secondary
• Volume Taken During the First 5 Min of Feeding (ml) VT5
during each feed taken orally by neonate VT5 is the amount of feed was taken by neonate during first 5 minutes
Time frame: Volume taken during the first 5 min of feeding (ml) VT5 was measured on D1, D2, D3, D5, D7 and D14
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intervention Group (Group 1) | • Volume Taken During the First 5 Min of Feeding (ml) VT5 | VT5 on D1 | 2 ml |
| Intervention Group (Group 1) | • Volume Taken During the First 5 Min of Feeding (ml) VT5 | VT5 on D2 | 3 ml |
| Intervention Group (Group 1) | • Volume Taken During the First 5 Min of Feeding (ml) VT5 | VT5 on D3 | 3 ml |
| Intervention Group (Group 1) | • Volume Taken During the First 5 Min of Feeding (ml) VT5 | VT5 on D5 | 5 ml |
| Intervention Group (Group 1) | • Volume Taken During the First 5 Min of Feeding (ml) VT5 | VT5 on D7 | 7 ml |
| Intervention Group (Group 1) | • Volume Taken During the First 5 Min of Feeding (ml) VT5 | VT5 on D14 | 10 ml |
| Control Group (Group 2) | • Volume Taken During the First 5 Min of Feeding (ml) VT5 | VT5 on D7 | 7 ml |
| Control Group (Group 2) | • Volume Taken During the First 5 Min of Feeding (ml) VT5 | VT5 on D1 | 2 ml |
| Control Group (Group 2) | • Volume Taken During the First 5 Min of Feeding (ml) VT5 | VT5 on D5 | 5 ml |
| Control Group (Group 2) | • Volume Taken During the First 5 Min of Feeding (ml) VT5 | VT5 on D2 | 3 ml |
| Control Group (Group 2) | • Volume Taken During the First 5 Min of Feeding (ml) VT5 | VT5 on D14 | 10 ml |
| Control Group (Group 2) | • Volume Taken During the First 5 Min of Feeding (ml) VT5 | VT5 on D3 | 3 ml |