Integrative Early Breastfeeding Support in NICU

Not Applicable

• Conditions: Premature
• Interventions: Behavioral: breastfeeding consultation

• Registration Number: NCT05301309
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-02
• Study First Submitted: 2022-02-28
• Study Start: 2022-03-16
• Study First Submitted QC: 2022-03-17
• Last Update Submitted: 2022-03-17
• Study First Posted: 2022-03-29
• Last Update Posted: 2022-03-29
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

• the mother of preterm baby whose gestational age is between 28 weeks and 34 6/7 weeks.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breastfeeding Consultation	breastfeeding consultation	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.
routine care	breastfeeding consultation	The control group only receive "breastfeeding for prematurity brochure" and routine care.

Primary Outcome Measures

Name	Time	Method
Neurobehavioral development	corrected age 6-month-old	Neurobehavioral development was evaluated by Bayley-III

Secondary Outcome Measures

Name	Time	Method
body weight	corrected age of 6-month-old	baby's body weight in grams
body height	corrected age of 6-month-old	baby's body height in centimetres
head circumference	corrected age of 6-month-old	baby's head circumference in centimetres
Breastfeeding Self-Efficacy Scale	corrected age of 6-month-old	Score of "Breastfeeding Self-Efficacy Scale", which minimum score is 14 and maximum score is 70. Higher scores mean better outcome.
Maternal Confidence Questionnaire	corrected age of 6-month-old	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.
Beck Depression Inventory-II	corrected age of 6-month-old	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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan