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临床试验/NCT03791749
NCT03791749已完成不适用

A Randomised Controlled Trial Testing the Use of a Simple Intervention on Maternal Psychological State, Breast Milk Composition and Volume, and Infant Behaviour and Growth.

University College, London1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2019年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Maternal stress change at 6 weeks from 2 weeks post-delivery.

研究概览

简要总结

Breastfeeding has various benefits for the mother and infant. It has the capability of reducing the risk of short term and long term problems for the infant, such as gastroenteritis, respiratory infections, type II diabetes and obesity, and of providing benefits for neurodevelopment. Breast milk offers even greater benefits for preterm infants. Some of the advantages of breastfeeding are related to the constituents of breast milk such as the macronutrients and bioactive factors, the hormones associated with breastfeeding such as oxytocin, and the behavioural aspects of breastfeeding (maternal sensitivity to infant cues). Despite these advantages, breastfeeding rates are below target levels mainly due to the challenges that women face that hinder breastfeeding success. Interventions aimed at improving policies, practices, and maternal support have been developed. However, other interventions that target specific modifiable barriers to breastfeeding can be useful.

The aim of this study is to investigate a simple support intervention for breastfeeding mothers of late preterm and early term infants on maternal stress reduction and infant weight gain. The investigators also aim to study the potential mechanisms by which this effect could be achieved (breast milk composition and volume, mother and infant behaviour).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Mothers of late preterm infants (34 to <37 weeks) or early term infants (37 to 38 weeks)
  • Intending to breastfeed for at least 6 weeks
  • Free from serious illness
  • Fluent in English

排除标准

  • Currently smoking or intending to smoke while breastfeeding
  • Not based in London
  • Prior breast surgery

结局指标

主要结局

Maternal stress change at 6 weeks from 2 weeks post-delivery.

时间窗: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)

Stress will be measured using the Perceived Stress Scale (0 to 40 points), where higher scores indicate a higher level of perceived stress.

Infant weight change at 6 weeks from 2 weeks post-delivery.

时间窗: Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally)

Infant weight (kg) will be measured using an infant weighing scale.

次要结局

  • Infant behaviour change at 6 weeks from 2 weeks post-delivery.(Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally))
  • Breast milk hormones change at 6 weeks from 2 weeks post-delivery.(Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally))
  • Mother-infant attachment change at 6 weeks from 2 weeks post-delivery.(Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally))
  • Breast milk composition (macronutrients) change at 6 weeks from 2 weeks post-delivery.(Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally))
  • Breast milk volume change at 6 weeks from 2 weeks post-delivery.(Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally))
  • Infant appetite change at 6 weeks from 2 weeks post-delivery.(Home visit 1 (2 weeks postnatally) and Home visit 2 (6 weeks postnatally))
  • Exclusive Breastfeeding Status(6 weeks, 3 months and 6 months postnatally)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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