Intervention Studies, Premature Birth of Newborn
Conditions
Keywords
Infant, Premature, Intervention Studies, Bottle feeding
Brief summary
This is randomized controlled trial investigating the effects of direct swallowing training and oral sensorimotor stimulation in preterm infants on oral feeding performance.
Interventions
OTHERDirect swallowing training (DST)
The DST consists of placing a bolus of 0.05-0.2 mL of formula milk (if the parents refuse, distilled water) via a 1-mL syringe directly on the medial-posterior part of the tongue approximately at the level of the hard and soft palate junction. The volume is started with 0.05 mL, and increased in increments of 0.05 mL to a maximum of 0.2 mL until the swallowing reflex is observed. Once the minimal volume necessary to initiate the swallow reflex is identified, it is used for the duration of the training. The bolus is provided every 30 sec over the 15-minute program or as tolerated. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.
OTHEROral sensorimotor stimulation (OSMS)
The OSMS consists of a 15-minute stimulation program, whereby the first 12 minutes involve stroking the cheeks, lips, gums, and tongue, and the final 3 minutes consist of sucking on a pacifier. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.
OTHERSham intervention
The sham intervention consisted of the therapists placing his/her hands into the incubator or bassinet for 15 minutes without touching the infants. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
Allocation is concealed from all investigators, nurses, doctors, and parents, with the sole exception of the occupational therapists, who provided the interventions.
Eligibility
Sex/Gender
ALL
Age
22 Weeks to 31 Weeks
Healthy volunteers
No
Inclusion criteria
* Preterm infants : before 32+0 weeks gestation * Infants who are receiving full tube feeding (more than 120 ml/kg/day) * Infants who discontinue of nasal continuous positive airway pressure before postmenstrual age 33+0 weeks * 'Feeders and growers' * The parents of the subject voluntarily sign the informed consent
Exclusion criteria
* Major congenital anomalies : face, central nervous system, gastrointestine, heart, etc * Gastrointestinal complications * Chronic medical complications : Intraventricular hemorrhage ≥ Grade III, periventricular leukomalacia, surgical necrotizing enterocolitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days From Start to Independent Oral Feeding | From date of starting oral feeding until the date of independent, full oral feeding, an expected average of 3 weeks | Days from start to independent oral feeding (independent oral feeding, 2 days in a row with no adverse events that do not self-resolve - The first successful day) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days From Start to Complete Full Oral Feeding | From date of starting oral feeding until the date of complete oral full feeding, an expected average of 3-4weeks | complete full oral feeding : 2 days in a row without any adverse events The first successful day) |
| Overall Transfer | Total number of assessment : 3 times ( 1. starting oral feeding, 2. volume of oral feeding/total feeding volume x 100 = 50%, 3. volume of oral feeding/total feeding volume) x 100 = 100% | % volume taken/volume prescribed |
| Proficiency | Total number of assessment : 3 times ( 1. starting oral feeding, 2. volume of oral feeding/total feeding volume x 100 = 50%, 3. volume of oral feeding/total feeding volume) x 100 = 100% | % volume taken at 5 min/volume prescribed |
| Rate of Transfer | Total number of assessment : 3 times ( 1. starting oral feeding, 2. volume of oral feeding/total feeding volume x 100 = 50%, 3. volume of oral feeding/total feeding volume) x 100 = 100% | mL/min volume of milk consumed relative to the duration of the oral Feeding session |
| Volume Loss | Total number of assessment : 3 times ( 1. starting oral feeding, 2. volume of oral feeding/total feeding volume x 100 = 50%, 3. volume of oral feeding/total feeding volume) x 100 = 100% | % volume of milk spilled from the lips as a percentage of the total milk transferred |
| Neonatal Oral Motor Assessment Scale (NOMAS) | Total number of assessment : 2 times ( 1. 3-5 days after starting oral feeding, 2. within 3 days after stopping intervention) | * comprehensive description of the infant's feeding patterns * identify normal oral-motor patterns and to differentiate disorganized from dysfunctional patterns |
| Days From Start to First Full Oral Feeding | From date of starting oral feeding until the date of first full oral feeding, an expected average of 2 weeks | first full oral feeding : The first day that attain the full oral feeding regardless of feeding side effects |
| Bayley Scales of Infant and Toddler Development, Third Edition | Corrected age 18-24 months | * an individually administered instrument designed to assess the developmental functioning of infants, toddlers, and young children. * cognitive scale, motor scale (gross motor, fine motor), language scale (receptive communication, expressive communication) * subtest total raw scores & scaled scores / composite scores /percentile ranks/ confidence intervals * Total raw score range (min\ max) : cognitive (0\ 91), receptive communication (0\ 49), expressive communication (0\ 48), fine motor (0\ 66), gross motor (0\ 72) * Higher scores mean better outcomes |
| Korean Version of MacArthur-Bates Communicative Development Inventories (K M-B CDI) | postnatal age 36±2 months | -a simple screening test for language development |
| Korean-Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI)-Fourth Edition. | aged 4:00~4:11 years | * An innovative measure of cognitive development and an intelligence test for preschoolers and young children * Primary index scales\> verbal comprehension, visual spatial, fluid reasoning, working memory, processing speed ==\> Full scale IQ * Ancillary index scales \> vocabulary acquisition * scaled score, composite score, percentile rank, CI * Range of Full scale IQ : min (40) \ max (160) * Higher scores mean better outcomes. |
| Korean Developmental Screening Test | postnatal age 48±3 months | * A fill-up questionnaire to be answered by parents so as to determine who experience developmental problems * Domains: gross motor, fine motor, language, cognition, sociality, self-care * Score range of each domain : min (0) \ max (24) * Higher scores mean better outcomes. |
| Strengths and Difficulties Questionnaire | postnatal age 48±3 months | * a brief behavioural screening questionnaire * 5 subscales: Emotional problems scale, Conduct problems scale, Hyperactivity scale, Peer problems scale, Prosocial scale (score range of each scale : 0-10) * total difficulties score : summing scores from all the scales except the prosocial scale (score range : 0-40) * Lower scores mean better outcomes for the all scales except the prosocial scale |
| Behavioral Pediatrics Feeding Assessment Scale (BPFAS) | postnatal age 48±3 months | * A comprehensive and widely used measure of behavioral and skill-based feeding problems * It consists of 35 questions: 25 related to child eating, and 10 related to parent feeding behaviors. * Parents answer each question on a five-point Likert scale, then indicate whether they perceive that behavior to be problematic or not. * Child an parent frequency scores : from the Likert scales (score range : min 35 \ max 175) * Child and parent problem scores : from the yes/no questions |
| Length of Hospital Stay | From date of admission until the date of discharge, through study completion, expected average days of 3 month | Length of hospital stay |
Countries
South Korea
Participant flow
Recruitment details
Participants were recruited from the neonatal intensive care unit of Seoul National University Children's Hospital between July 2015 and July 2020. Infants were enrolled if they were (1) born before 32 weeks' gestation; (2) receiving full tube feeding (≥120 mL/kg/day); (3) weaned from nasal continuous positive airway pressure (NCPAP) before 33 weeks' postmenstrual age (PMA); and (4) 'feeders and growers'.
Participants by arm
| Arm | Count |
|---|---|
| Control Two 15-minute sessions of sham intervention/day, five days a week
Sham intervention: The sham intervention consisted of the therapists placing his/her hands into the incubator or bassinet for 15 minutes without touching the infants. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve. | 64 |
| DST Group One session of DST and the other of sham intervention/day, five days a week
Direct swallowing training (DST): The DST consists of placing a bolus of 0.05-0.2 mL of formula milk (if the parents refuse, distilled water) via a 1-mL syringe directly on the medial-posterior part of the tongue approximately at the level of the hard and soft palate junction. The volume is started with 0.05 mL, and increased in increments of 0.05 mL to a maximum of 0.2 mL until the swallowing reflex is observed. Once the minimal volume necessary to initiate the swallow reflex is identified, it is used for the duration of the training. The bolus is provided every 30 sec over the 15-minute program or as tolerated. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.
Sham intervention: The sham intervention consisted of the therapists placing his/her hands into the incubator or bassinet for 15 minutes without touching the infants. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve. | 64 |
| DST+OSMS Group One session of DST and the other of OSMS/day, five days a week
Direct swallowing training (DST): The DST consists of placing a bolus of 0.05-0.2 mL of formula milk (if the parents refuse, distilled water) via a 1-mL syringe directly on the medial-posterior part of the tongue approximately at the level of the hard and soft palate junction. The volume is started with 0.05 mL, and increased in increments of 0.05 mL to a maximum of 0.2 mL until the swallowing reflex is observed. Once the minimal volume necessary to initiate the swallow reflex is identified, it is used for the duration of the training. The bolus is provided every 30 sec over the 15-minute program or as tolerated. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.
Oral sensorimotor stimulation (OSMS): The OSMS consists of a 15-minute stimulation program, whereby the first 12 minutes involve stroking the cheeks, lips, gums, and tongue, and the final 3 minutes consist of sucking on a pacifier. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve. | 61 |
| Total | 189 |
Baseline characteristics
| Characteristic | DST Group | DST+OSMS Group | Total | Control |
|---|---|---|---|---|
| Age, Continuous | 29 weeks STANDARD_DEVIATION 1 | 29 weeks STANDARD_DEVIATION 2 | 29 weeks STANDARD_DEVIATION 1 | 28 weeks STANDARD_DEVIATION 1 |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment South Korea | 64 participants | 61 participants | 189 participants | 64 participants |
| Sex: Female, Male Female | 30 Participants | 28 Participants | 89 Participants | 31 Participants |
| Sex: Female, Male Male | 34 Participants | 33 Participants | 100 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 64 | 1 / 61 |
| other Total, other adverse events | 9 / 64 | 5 / 64 | 5 / 61 |
| serious Total, serious adverse events | 0 / 64 | 0 / 64 | 1 / 61 |
Outcome results
Primary
Days From Start to Independent Oral Feeding
Days from start to independent oral feeding (independent oral feeding, 2 days in a row with no adverse events that do not self-resolve - The first successful day)
Time frame: From date of starting oral feeding until the date of independent, full oral feeding, an expected average of 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Days From Start to Independent Oral Feeding | 21.1 days | Standard Deviation 15.3 |
| DST Group | Days From Start to Independent Oral Feeding | 17.2 days | Standard Deviation 9.9 |
| DST+OSMS Group | Days From Start to Independent Oral Feeding | 14.8 days | Standard Deviation 9.4 |
Secondary
Bayley Scales of Infant and Toddler Development, Third Edition
* an individually administered instrument designed to assess the developmental functioning of infants, toddlers, and young children. * cognitive scale, motor scale (gross motor, fine motor), language scale (receptive communication, expressive communication) * subtest total raw scores & scaled scores / composite scores /percentile ranks/ confidence intervals * Total raw score range (min\ max) : cognitive (0\ 91), receptive communication (0\ 49), expressive communication (0\ 48), fine motor (0\ 66), gross motor (0\ 72) * Higher scores mean better outcomes
Time frame: Corrected age 18-24 months
Secondary
Behavioral Pediatrics Feeding Assessment Scale (BPFAS)
* A comprehensive and widely used measure of behavioral and skill-based feeding problems * It consists of 35 questions: 25 related to child eating, and 10 related to parent feeding behaviors. * Parents answer each question on a five-point Likert scale, then indicate whether they perceive that behavior to be problematic or not. * Child an parent frequency scores : from the Likert scales (score range : min 35 \ max 175) * Child and parent problem scores : from the yes/no questions
Time frame: postnatal age 48±3 months
Secondary
Days From Start to Complete Full Oral Feeding
complete full oral feeding : 2 days in a row without any adverse events The first successful day)
Time frame: From date of starting oral feeding until the date of complete oral full feeding, an expected average of 3-4weeks
Secondary
Days From Start to First Full Oral Feeding
first full oral feeding : The first day that attain the full oral feeding regardless of feeding side effects
Time frame: From date of starting oral feeding until the date of first full oral feeding, an expected average of 2 weeks
Secondary
Korean Developmental Screening Test
* A fill-up questionnaire to be answered by parents so as to determine who experience developmental problems * Domains: gross motor, fine motor, language, cognition, sociality, self-care * Score range of each domain : min (0) \ max (24) * Higher scores mean better outcomes.
Time frame: postnatal age 48±3 months
Secondary
Korean Version of MacArthur-Bates Communicative Development Inventories (K M-B CDI)
-a simple screening test for language development
Time frame: postnatal age 36±2 months
Secondary
Korean-Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI)-Fourth Edition.
* An innovative measure of cognitive development and an intelligence test for preschoolers and young children * Primary index scales\> verbal comprehension, visual spatial, fluid reasoning, working memory, processing speed ==\> Full scale IQ * Ancillary index scales \> vocabulary acquisition * scaled score, composite score, percentile rank, CI * Range of Full scale IQ : min (40) \ max (160) * Higher scores mean better outcomes.
Time frame: aged 4:00~4:11 years
Secondary
Length of Hospital Stay
Length of hospital stay
Time frame: From date of admission until the date of discharge, through study completion, expected average days of 3 month
Secondary
Neonatal Oral Motor Assessment Scale (NOMAS)
* comprehensive description of the infant's feeding patterns * identify normal oral-motor patterns and to differentiate disorganized from dysfunctional patterns
Time frame: Total number of assessment : 2 times ( 1. 3-5 days after starting oral feeding, 2. within 3 days after stopping intervention)
Secondary
Overall Transfer
% volume taken/volume prescribed
Time frame: Total number of assessment : 3 times ( 1. starting oral feeding, 2. volume of oral feeding/total feeding volume x 100 = 50%, 3. volume of oral feeding/total feeding volume) x 100 = 100%
Secondary
Proficiency
% volume taken at 5 min/volume prescribed
Time frame: Total number of assessment : 3 times ( 1. starting oral feeding, 2. volume of oral feeding/total feeding volume x 100 = 50%, 3. volume of oral feeding/total feeding volume) x 100 = 100%
Secondary
Rate of Transfer
mL/min volume of milk consumed relative to the duration of the oral Feeding session
Time frame: Total number of assessment : 3 times ( 1. starting oral feeding, 2. volume of oral feeding/total feeding volume x 100 = 50%, 3. volume of oral feeding/total feeding volume) x 100 = 100%
Secondary
Strengths and Difficulties Questionnaire
* a brief behavioural screening questionnaire * 5 subscales: Emotional problems scale, Conduct problems scale, Hyperactivity scale, Peer problems scale, Prosocial scale (score range of each scale : 0-10) * total difficulties score : summing scores from all the scales except the prosocial scale (score range : 0-40) * Lower scores mean better outcomes for the all scales except the prosocial scale
Time frame: postnatal age 48±3 months
Secondary
Volume Loss
% volume of milk spilled from the lips as a percentage of the total milk transferred
Time frame: Total number of assessment : 3 times ( 1. starting oral feeding, 2. volume of oral feeding/total feeding volume x 100 = 50%, 3. volume of oral feeding/total feeding volume) x 100 = 100%