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临床试验/NCT05301309
NCT05301309Unknown不适用

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

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年3月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
44
试验地点
1
主要终点
Neurobehavioral development

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • the mother of preterm baby whose gestational age is between 28 weeks and 34 6/7 weeks.

排除标准

  • 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

研究组 & 干预措施

Breastfeeding Consultation

Experimental

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.

干预措施: breastfeeding consultation (Behavioral)

routine care

Active Comparator

The control group only receive "breastfeeding for prematurity brochure" and routine care.

干预措施: breastfeeding consultation (Behavioral)

结局指标

主要结局

Neurobehavioral development

时间窗: corrected age 6-month-old

Neurobehavioral development was evaluated by Bayley-III

Neurobehavioral development

时间窗: corrected age 3-month-old

Neurobehavioral development was evaluated by Bayley-III

次要结局

  • body weight(corrected age of 6-month-old)
  • body height(corrected age of 6-month-old)
  • head circumference(corrected age of 6-month-old)
  • Breastfeeding Self-Efficacy Scale(corrected age of 6-month-old)
  • Maternal Confidence Questionnaire(corrected age of 6-month-old)
  • Beck Depression Inventory-II(corrected age of 6-month-old)
  • body height(corrected age of 3-month-old)
  • body weight(corrected age of 3-month-old)
  • head circumference(corrected age of 3-month-old)
  • Breastfeeding Self-Efficacy Scale(at birth)
  • Breastfeeding Self-Efficacy Scale(corrected age of 3-month-old)
  • Beck Depression Inventory-II(at birth)
  • Beck Depression Inventory-II(corrected age of 3-month-old)
  • Maternal Confidence Questionnaire(at birth)
  • Maternal Confidence Questionnaire(corrected age of 3-month-old)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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