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临床试验/NCT05100550
NCT05100550Unknown不适用

Family-based Health Education Program and Zinc Supplementation for Stunted Mother and Its Impact on Biomarker of Growth in Baby

Hasanuddin University2 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
126
试验地点
2
主要终点
Infant weight

研究概览

简要总结

Background :

It is important to tackle the issue of malnutrition at an early stage. A stunted mother has a tendency of having adverse neonatal outcomes including growth restriction. The multidisciplinary intervention followed by micronutrient supplementation is developed to prevent these adverse outcomes. Zinc has been associated with better neonatal growth and brain growth. This study aims to assess the impact of family-based health education programs plus zinc supplementation on the important biomarker of pregnancy and neonatal growth.

Objective :

  1. To assess the impact of Family-based health education programs plus zinc supplementation on the outcome of pregnancy in stunted mother
    1. To assess the impact of Family-based health education programs plus zinc supplementation on the outcome of neonatal growth in stunted mother

Methodology :

A Quasi-experimental study involving stunted pregnant mother with parallel intervention

Hypothesis :

Mother who receives the intervention will have the better maternal and neonatal outcome

详细描述

Details of Family-Based Health Education Program + Zinc :

  1. Home-visit and health promotion by trained midwives
  2. Supervision by health volunteer
  3. Zinc Supplementation

General target population :

  1. Stunted pregnant mother on the third trimester of pregnancy
  2. Conducted in Primary Health Care Center

Design of Study :

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Body height is less than 150 cm
  • Upper Arm Circumference less than 23.5 cm
  • Family income is less than Rp 2,500,000,- following the minimum wage of targeted area
  • 24-26 weeks pregnant.

排除标准

  • has pregnancy complications
  • multiple infants
  • refuse to follow the protocol

结局指标

主要结局

Infant weight

时间窗: changes of weight at birth up to 6 months

This includes weight at birth, weight at 3 months and 6 months

Infant Length

时间窗: changes of length at birth up to 6 months

This includes length of body at birth, at 3 months and 6 months

次要结局

  • Hemoglobin level of mother(changes of hemoglobin level of mother from the baseline to delivery time)
  • Insulin-like growth factor 1 (IGF-1) of infant(changes of IGF-1 level of infant from the day of birth to 6 months)
  • Tumor Growth Factor Beta 1 (TGF beta 1) of infant(changes of TGF Beta 1 level of infant from the day of birth to 6 months)
  • Zinc level of mother in blood(changes of Zinc in blood of mother from the baseline to 6 months after delivery)
  • Zinc level of mother in breast milk(changes of Zinc in breast milk of mother from the delivery day to 6 months after delivery)
  • Hemoglobin level of infant(changes of hemoglobin level of infant from the day of birth to 6 months)
  • Insulin-like growth factor 1 (IGF-1) of mother(changes of IGF-1 level of mother from the baseline to day of delivery)
  • Brain-derived neurotrophic Factor (BDNF) of infant(changes of BDNF level of infant from the day of birth to 6 months)

研究者

发起方
Hasanuddin University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bumi Herman

Assistant Lecturer

Hasanuddin University

研究点 (2)

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