Integrative Early Breastfeeding Support in NICU

Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05301309
• Other study ID #: 202106048RIND
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2022
• Source: National Taiwan University Hospital
• Contact: Pei-Yu Yang, MSc
• Phone: +886-2-23123456
• Email: ptpeiyuyang[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Premature

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurobehavioral development	Neurobehavioral development was evaluated by Bayley-III	corrected age 3-month-old
Primary	Neurobehavioral development	Neurobehavioral development was evaluated by Bayley-III	corrected age 6-month-old
Secondary	body height	baby's body height in centimetres	corrected age of 3-month-old
Secondary	body height	baby's body height in centimetres	corrected age of 6-month-old
Secondary	body weight	baby's body weight in grams	corrected age of 3-month-old
Secondary	body weight	baby's body weight in grams	corrected age of 6-month-old
Secondary	head circumference	baby's head circumference in centimetres	corrected age of 3-month-old
Secondary	head circumference	baby's head circumference in centimetres	corrected age of 6-month-old
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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