Breastfeeding
Conditions
Keywords
Skin to skin contact, Salivary cortisol, Breast feeding Behavior
Brief summary
Aims and Objectives Aim To determine the effect of delivery room Skin To Skin contact on breast feeding behavior of term neonates born by normal vaginal delivery at 36-48 hours. Objectives Primary objective To determine the effect of delivery room Skin To Skin contact on breast feeding behaviour of term neonates born by normal vaginal delivery, between 36-48 hours (as measured by Infant Breast Feeding Score) by video recording using a randomized controlled design. Secondary objectives To determine the effect of delivery room Skin to Skin contact on 1. Salivary cortisol at 6 hours as measured by electrochemiluminescence immunoassay (ECLIA) 2. Weight at 48 hours as measured by digital infant weighing scale. 3. Maternal perception of breast milk output, breast consistency, infant's feeding and activity at 36-48 hours as measured by a score graded as very satisfied, satisfied, acceptable and not satisfied. 4. Number and duration of feeding sessions till 48 hrs according to the mother as assessed at 48 hours 5. Breast feeding rates at 6 weeks measured at the time of vaccination at the time of visit to the hospital for the same or as asked by telephonic conversation. Hypothesis Infants receiving skin to skin contact when compared with neonates not receiving it, demonstrate better breast feeding behaviour.
Detailed description
Inclusion and exclusion criteria for the enrollment of subjects in the study Inclusion criteria Term babies born to mothers by normal vaginal delivery in the study period. Exclusion criteria 1. Babies with major congenital malformation. 2. Multiple pregnancy 3. Babies requiring resuscitation beyond the initial steps 4. Babies requiring care in the neonatal intensive care unit. 5. Maternal problems requiring immediate care * Severe preeclampsia defined as Blood pressure more than 160/110, Proteinuria more than 3+, Oliguria less than 500 ml, Pulmonary edema, cerebral visual disturbances, Impaired liver function, Thrombocytopenia, Epigastric Pain * Imminent eclampsia * Severe bleeding * Mother with significant surgical or medical illness requiring separation of the baby from the mother. 6. Small for dates and large for dates babies 7. Infants of diabetic mother 8. Maternal refusal of consent Outcome Measures: 1. Measurement of Breast feeding Behavior at 36-48 hours using Infant Breast feeding Behavior scale 2. Salivary Cortisol 3. Weight at birth 4. Weight at 48 hours 5. Number of feeding sessions till 48 hours 6. Maternal Perception of Infant activity, feeding and breast milk output.
Interventions
OTHERskin to skin contact
Infants randomized to SSC group were placed prone over the mother's chest immediately after birth. Skin-to-skin contact was continued for the next two hours. breastfeeding at the time of discharge.
OTHERControl group
The infants who were allocated to the conventional care (control group) were kept by the mother's side and did not receive early SSC.
Sponsors
All India Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Term babies born to mothers by normal vaginal delivery in the study period.
Exclusion criteria
1. Babies with major congenital malformation. 2. Multiple pregnancy 3. Babies requiring resuscitation beyond the initial steps 4. Babies requiring care in the neonatal intensive care unit. 5. Maternal problems requiring immediate care * Severe preeclampsia defined as Blood pressure more than 160/110, Proteinuria more than 3+, Oliguria less than 500 ml, Pulmonary edema, cerebral visual disturbances, Impaired liver function, Thrombocytopenia, Epigastric Pain * Imminent eclampsia * Severe bleeding * Mother with significant surgical or medical illness requiring separation of the baby from the mother. 6. Small for dates and large for dates babies 7. Infants of diabetic mother 8. Maternal refusal of consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Median Breast Feeding Score | 36-48 hours by video recording | This was a one point assessment done at 36-48 hours by video recording. The video recording was carried out in a separate well lighted room after taking informed consent from the mother. The mother had full right to see the video and only if she was satisfied, was then the video finally stored. These videos were analyzed later using the infant breast feeding assessment tool : a scoring measure \[0 to 3\] for i) readiness to feed ii) sucking iii) rooting and iv) latching. The total possible score could vary from 0 to 12, with 12 being the best possible total score. Successful breastfeeding was defined as a total score of more \>=8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Salivary Cortisol | 6 hours | Saliva samples were collected with a Salivette. The infant had to suck on the swab for atleast 5 minutes. The prerequisite for collection of the saliva included that the infant should not have fed atleast 2 hours prior to the collection of the salivary sample. The filtrates were then transferred to a separate tube and were stored at 2-8º C for 24 hours. They were later transported to the central laboratory where the samples were stored at -20ºC and later analyzed using electrochemiluminescence immunoassay (ECLIA). |
| Breast Feeding Status at 48 Hours | 48 hours | The mother was given a form at the time of birth of the baby for recording the duration of each breast feeding session and documentation of any supplemental feeds taken from the neonatal intensive care unit. The number and the amount of supplemental feeds was confirmed with the nursing staff on duty when in the hospital and with the mother at 6 weeks when she reported for the first vaccination or by telephonic contact with her at 6 weeks. This was recorded by the principal investigator and crosschecked by the second investigator in all cases. |
| Breast Feeding Status at 6 Weeks | 6 weeks | The mother was given a form at the time of birth of the baby for recording the duration of each breast feeding session and documentation of any supplemental feeds taken from the neonatal intensive care unit. The number and the amount of supplemental feeds was confirmed with the nursing staff on duty when in the hospital and with the mother at 6 weeks when she reported for the first vaccination or by telephonic contact with her at 6 weeks. This was recorded by the principal investigator and crosschecked by the second investigator in all cases |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Skin to Skin Contact Babies in this arm will be given skin to skin contact for at least 2 hours after birth | 20 |
| Control Group baby will be kept by the mothers side and not given skin to skin contact | 21 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Consent refusal | 2 | 2 |
| Overall Study | Poor quality video | 1 | 1 |
Baseline characteristics
| Characteristic | Skin to Skin Contact | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 20 Participants | 21 Participants | 41 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 38 weeks STANDARD_DEVIATION 0.91 | 38 weeks STANDARD_DEVIATION 1.2 | 38 weeks STANDARD_DEVIATION 0.98 |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Male | 10 Participants | 13 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 21 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 |
Outcome results
Primary
The Median Breast Feeding Score
This was a one point assessment done at 36-48 hours by video recording. The video recording was carried out in a separate well lighted room after taking informed consent from the mother. The mother had full right to see the video and only if she was satisfied, was then the video finally stored. These videos were analyzed later using the infant breast feeding assessment tool : a scoring measure \[0 to 3\] for i) readiness to feed ii) sucking iii) rooting and iv) latching. The total possible score could vary from 0 to 12, with 12 being the best possible total score. Successful breastfeeding was defined as a total score of more \>=8.
Time frame: 36-48 hours by video recording
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Skin to Skin Contact | The Median Breast Feeding Score | 8 scores |
| Control Group | The Median Breast Feeding Score | 9 scores |
Secondary
Breast Feeding Status at 48 Hours
The mother was given a form at the time of birth of the baby for recording the duration of each breast feeding session and documentation of any supplemental feeds taken from the neonatal intensive care unit. The number and the amount of supplemental feeds was confirmed with the nursing staff on duty when in the hospital and with the mother at 6 weeks when she reported for the first vaccination or by telephonic contact with her at 6 weeks. This was recorded by the principal investigator and crosschecked by the second investigator in all cases.
Time frame: 48 hours
Population: EBF rates were assessed using the standard WHO definitions. We asked the mothers about the method of feeding and the number and amount of supplemental feeds received in the first 2 days of life. Breastfeeding rates at 6 weeks were obtained by enquiring from the mothers at the time of the first vaccination of their infants in the follow-up clinic.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Skin to Skin Contact | Breast Feeding Status at 48 Hours | 95 percentage of partcipants |
| Control Group | Breast Feeding Status at 48 Hours | 38 percentage of partcipants |
Comparison: Exclusive breast feeding at 48 hours was 95% (19 out of 20 partcipants were exclusively breast feeding)in the skin-to-skin contact group vs. 38.1% in the control groupp-value: 095% CI: [1.4, 4.3]Wilcoxon (Mann-Whitney)
Secondary
Breast Feeding Status at 6 Weeks
The mother was given a form at the time of birth of the baby for recording the duration of each breast feeding session and documentation of any supplemental feeds taken from the neonatal intensive care unit. The number and the amount of supplemental feeds was confirmed with the nursing staff on duty when in the hospital and with the mother at 6 weeks when she reported for the first vaccination or by telephonic contact with her at 6 weeks. This was recorded by the principal investigator and crosschecked by the second investigator in all cases
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Skin to Skin Contact | Breast Feeding Status at 6 Weeks | 90 percentage of partcipants |
| Control Group | Breast Feeding Status at 6 Weeks | 28 percentage of partcipants |
p-value: 0.00195% CI: [1.6, 6.3]Wilcoxon (Mann-Whitney)
Secondary
Salivary Cortisol
Saliva samples were collected with a Salivette. The infant had to suck on the swab for atleast 5 minutes. The prerequisite for collection of the saliva included that the infant should not have fed atleast 2 hours prior to the collection of the salivary sample. The filtrates were then transferred to a separate tube and were stored at 2-8º C for 24 hours. They were later transported to the central laboratory where the samples were stored at -20ºC and later analyzed using electrochemiluminescence immunoassay (ECLIA).
Time frame: 6 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Skin to Skin Contact | Salivary Cortisol | 0.90 microgram/dl |
| Control Group | Salivary Cortisol | 0.54 microgram/dl |
p-value: 0.4Wilcoxon (Mann-Whitney)