Integrative Early Breastfeeding Support in NICU
The Effects of Integrative Early Breastfeeding Support and Intervention Program on Preterm Infants' Breastfeeding Rate and Neurobehavioral Development and Maternal Mental Health
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2022
CompletedStudy Start
First participant enrolled
March 16, 2022
CompletedFirst Posted
Study publicly available on registry
March 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMarch 29, 2022
February 1, 2022
10 months
February 28, 2022
March 17, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (15)
body height
corrected age of 3-month-old
body height
corrected age of 6-month-old
body weight
corrected age of 3-month-old
body weight
corrected age of 6-month-old
head circumference
corrected age of 3-month-old
- +10 more secondary outcomes
Study Arms (2)
Breastfeeding Consultation
EXPERIMENTALThe 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
ACTIVE COMPARATORThe control group only receive "breastfeeding for prematurity brochure" and routine care.
Interventions
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.
Eligibility Criteria
You may qualify if:
- the mother of preterm baby whose gestational age is between 28 weeks and 34 6/7 weeks.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pei-Yu Yang, MSc
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2022
First Posted
March 29, 2022
Study Start
March 16, 2022
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
March 29, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share