Clinical trial NCT05301309: Integrative Early Breastfeeding Support in NICU
Official title: The Effects of Integrative Early Breastfeeding Support and Intervention Program on Preterm Infants' Breastfeeding Rate and Neurobehavioral Development and Maternal Mental Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 44
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neurobehavioral development
timeFrame: corrected age 3-month-old
measure: Neurobehavioral development
timeFrame: corrected age 6-month-old
Secondary outcomes:
measure: body height
timeFrame: corrected age of 3-month-old
measure: body height
timeFrame: corrected age of 6-month-old
measure: body weight
timeFrame: corrected age of 3-month-old
measure: body weight
timeFrame: corrected age of 6-month-old
measure: head circumference
timeFrame: corrected age of 3-month-old
measure: head circumference
timeFrame: corrected age of 6-month-old
measure: Breastfeeding Self-Efficacy Scale
timeFrame: at birth
measure: Breastfeeding Self-Efficacy Scale
timeFrame: corrected age of 3-month-old
measure: Breastfeeding Self-Efficacy Scale
timeFrame: corrected age of 6-month-old
measure: Beck Depression Inventory-II
timeFrame: at birth
measure: Beck Depression Inventory-II
timeFrame: corrected age of 3-month-old
measure: Beck Depression Inventory-II
timeFrame: corrected age of 6-month-old
measure: Maternal Confidence Questionnaire
timeFrame: at birth
measure: Maternal Confidence Questionnaire
timeFrame: corrected age of 3-month-old
measure: Maternal Confidence Questionnaire
timeFrame: corrected age of 6-month-old
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Pei-Yu Yang, MSc
role: STUDY_DIRECTOR
References: