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Integrative Early Breastfeeding Support in NICU

NCT05301309 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-03-29

No results posted yet for this study

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.

Conditions

  • Premature

Interventions

BEHAVIORAL

breastfeeding consultation

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.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Pei-Yu Yang, MSc · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-16
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05301309 on ClinicalTrials.gov