Integrative Early Breastfeeding Support in NICU

Study Overview
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Brief Summary
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Background and Purpose: Preterm infants are suffered from preterm-related medical sequelae and neurobehavioral problems, which required interdisciplinary intervention. Breast milk is the best nutrition for preterm infants. However, consistent breastfeeding is quite challenging to most mothers of prematurity. The purpose of this study is to investigate the effect of integrative early breastfeeding support and intervention programs on preterm infants' breastfeeding rate, neurobehavioral development, and maternal mental health. Method: The prospective, single-blinded randomized controlled trial would be conducted in National Taiwan University Children's Hospital in Taipei, Taiwan. We would recruit the mother and infant dyad whose gestational age is between 28 weeks and 34 6/7 weeks. The intervention group (n=22) would receive integrative early breastfeeding support and intervention programs, including breastfeeding for prematurity brochure, group education class, weekly interview, one-by-one breastfeeding consultation and online peer group support. The control group (n=22) only receive breastfeeding for prematurity brochure and routine care. Outcome measure: the growth date and types of feeding data at birth, discharge from hospital, 3- and 6-month-old of corrected age would be collected by medical chart review or by interview. Maternal health condition would evaluate by 3 questionnaires, including Breastfeeding Self-Efficacy Scale, Beck Depression Inventory-II and Maternal Confidence Questionnaire. Neurobehavioral development would be measured using Neonatal Neurobehavioral Evaluation-Chinese version and Bayley Scales of infant and toddler development 3rd edition at corrected age of 3-month-old and 6-month-old separately. Demographic data, birth history, types of breastfeeding data would be compared with independent t test or χ2 test. The effect of integrative early breastfeeding support and intervention on growth of preterm infants, neurobehavioral development, types of feeding, and maternal health would be conducted by logistic regression analysis.

Detailed Description
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Preterm infants are suffered from preterm-related medical sequelae and neurobehavioral problems, which required interdisciplinary intervention. Breast milk is the best nutrition for preterm infants. However, consistent breastfeeding is quite challenging to most mothers of prematurity. The purpose of this study is to investigate the effect of integrative early breastfeeding support and intervention programs on preterm infants' breastfeeding rate, neurobehavioral development, and maternal mental health. Method: The prospective, single-blinded randomized controlled trial would be conducted in National Taiwan University Children's Hospital in Taipei, Taiwan. We would recruit the mother and infant dyad whose gestational age is between 28 weeks and 34 6/7 weeks. The intervention group (n=22) would receive integrative early breastfeeding support and intervention programs, including breastfeeding for premature brochure, group education class, weekly interview, one-by-one breastfeeding consultation (at least once during admission) and online peer group support. The control group (n=22) only receive breastfeeding for premature brochure and routine care. Outcome measure: the growth data (including height, weight and head circumference) and types of feeding data at birth, discharge from hospital, 3- and 6-month-old of corrected age would be collected by medical chart review or by interview. Maternal health condition would evaluate by 3 questionnaires, including Breastfeeding Self-Efficacy Scale, Beck Depression Inventory-II and Maternal Confidence Questionnaire. Neuro-behavioral development would be measured using Neonatal Neurobehavioral Evaluation-Chinese version and Bayley Scales of infant and toddler development 3rd edition at corrected age of 3-month-old and 6-month-old separately. Demographic data, birth history, types of breastfeeding data would be compared with independent t test or χ2 test. The effect of integrative early breastfeeding support and intervention on growth of preterm infants, neurobehavioral development, types of feeding, and maternal health would be conducted by logistic regression analysis.

Official Title
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The Effects of Integrative Early Breastfeeding Support and Intervention Program on Preterm Infants' Breastfeeding Rate and Neurobehavioral Development and Maternal Mental Health

Conditions
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Premature

Intervention / Treatment
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* Behavioral: breastfeeding consultation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the mother of preterm baby whose gestational age is between 28 weeks and 34 6/7 weeks. Exclusion Criteria: mother less than 20-years-old not intend to breastfeed baby's vital sign is not stable the need frequent medical intervention baby had congenital anomaly, gene anomaly, neurological disease, mitochondrial disease or metabolic diseases mother or baby receive major surgery

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breastfeeding Consultation<br>The intervention group would receive integrative early breastfeeding support and intervention programs, including breastfeeding for prematurity brochure, group education class, weekly interview, one-by-one breastfeeding consultation and online peer group support. | Behavioral: breastfeeding consultation<br>* Integrative early breastfeeding support and intervention programs: breastfeeding for prematurity brochure, group education class, weekly interview, one-by-one breastfeeding consultation and online peer group support.<br>|
| Active Comparator: routine care<br>The control group only receive breastfeeding for prematurity brochure and routine care. | Behavioral: breastfeeding consultation<br>* Integrative early breastfeeding support and intervention programs: breastfeeding for prematurity brochure, group education class, weekly interview, one-by-one breastfeeding consultation and online peer group support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurobehavioral development | Neurobehavioral development was evaluated by Bayley-III | corrected age 3-month-old | 
| Neurobehavioral development | Neurobehavioral development was evaluated by Bayley-III | corrected age 6-month-old | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body height | baby's body height in centimetres | corrected age of 3-month-old | 
| body height | baby's body height in centimetres | corrected age of 6-month-old | 
| body weight | baby's body weight in grams | corrected age of 3-month-old | 
| body weight | baby's body weight in grams | corrected age of 6-month-old | 
| head circumference | baby's head circumference in centimetres | corrected age of 3-month-old | 
| head circumference | baby's head circumference in centimetres | corrected age of 6-month-old | 
| Breastfeeding Self-Efficacy Scale | Score of Breastfeeding Self-Efficacy Scale, which minimum score is 14 and maximum score is 70. Higher scores mean better outcome. | at birth | 
| Breastfeeding Self-Efficacy Scale | Score of Breastfeeding Self-Efficacy Scale, which minimum score is 14 and maximum score is 70. Higher scores mean better outcome. | corrected age of 3-month-old | 
| Breastfeeding Self-Efficacy Scale | Score of Breastfeeding Self-Efficacy Scale, which minimum score is 14 and maximum score is 70. Higher scores mean better outcome. | corrected age of 6-month-old | 
| Beck Depression Inventory-II | Total score of Beck Depression Inventory-II. The highest possible total for the test would be 63, and the lowest total of the test would be 0. Higher scores mean worse outcome. | at birth | 
| Beck Depression Inventory-II | Total score of Beck Depression Inventory-II. The highest possible total for the test would be 63, and the lowest total of the test would be 0. Higher scores mean worse outcome. | corrected age of 3-month-old | 
| Beck Depression Inventory-II | Total score of Beck Depression Inventory-II. The highest possible total for the test would be 63, and the lowest total of the test would be 0. Higher scores mean worse outcome. | corrected age of 6-month-old | 
| Maternal Confidence Questionnaire | Total score of Maternal Confidence Questionnaire. The highest possible total for the test would be 70, and the lowest total of the test would be 14. Higher scores mean better outcome. | at birth | 
| Maternal Confidence Questionnaire | Total score of Maternal Confidence Questionnaire. The highest possible total for the test would be 70, and the lowest total of the test would be 14. Higher scores mean better outcome. | corrected age of 3-month-old | 
| Maternal Confidence Questionnaire | Total score of Maternal Confidence Questionnaire. The highest possible total for the test would be 70, and the lowest total of the test would be 14. Higher scores mean better outcome. | corrected age of 6-month-old |