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

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.

Study Overview

• Status: Recruiting
• Conditions: Premature
• Intervention / Treatment: Behavioral: breastfeeding consultation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pei-Yu Yang, MSc; Phone Number: 66515 +886-2-23123456; Email: ptpeiyuyang@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Pei-Yu Yang, MSc; Phone Number: +886-963566780; Email: ptpeiyuyang@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: routine care; The control group only receive "breastfeeding for prematurity brochure" and routine care.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Director: Pei-Yu Yang, MSc, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2022
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 202106048RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No