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临床试验/NCT04036240
NCT04036240Unknown不适用

Finger Feeding as a Method of Human Milk Supplementation in Low Birth Weight Infants After Discharge: a Randomized Controlled Trial

Fakultas Kedokteran Universitas Indonesia8 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2019年7月22日最近更新:
适应症

试验速览

阶段
不适用
入组人数
78
试验地点
8
主要终点
Breastfeeding rate

研究概览

简要总结

Human Milk Fortifier (HMF) is designed to supply additional calories, protein, vitamins and minerals to infants less than 37 weeks gestation or those less than 1500 g at birth. Liquid and powder types of HMF are available in the commercial market. Usually, one packet of powdered HMF is mixed to 25-50 cc expressed breast milk. Fortification of human milk is technically difficult in fully breastfed infants and artificial teats such as bottle feedings are common used. A study reported lower breastfeeding rate in intervention group who used HMF in comparison with control. Finger feeding method is associated with a better breastfeeding rate in hospital use. A feasibility study in Vienna reports finger feeding method as a way to provide fortification at home was acceptable.We hypothesize that finger feeding is an easy way for HMF supplementation after discharge to increase successful breastfeeding and improve growth in preterm and or low birth weight infants.

详细描述

For infants with very low birth weight (<1500 g) convincing evidence indicates that providing multi-nutrients fortification including protein, long-chain polyunsaturated fatty acid, and micro-nutrients improves infant growth during hospitalization and health outcomes. A study of predominantly breastfed preterm infants with fortification after discharge shows better growth than unsupplemented counterparts at 3 months corrected age. Another study showed that post discharged growth of < 1800 g infants with human milk fortifier (HMF) supplementation until 48 weeks gestational age improved. But without the intensive lactation counselling the breast milk in HMF group were lower than control group if artificial teats were used. 4. Finger feeding is an alternative method to feed infants to increase successful breastfeeding, but unpopular in Indonesia. Study on finger feeding are still limited and most study of them are not randomized trial. We evaluate the method of supplementation on breastfeeding rate, growth and safety. We also do in depth interview with those who have high or low compliance.

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
None

入排标准

年龄范围
3 Days 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • birth weight < 2500 g
  • need HMF supplementation after discharge
  • predominantly breastfed
  • live in Jakarta city and its surrounding
  • parents agree to follow study procedure with signed informed consent

排除标准

  • major congenital anomaly or other conditions interfere with normal growth and oral feeding

结局指标

主要结局

Breastfeeding rate

时间窗: 28 days

Formula used (ml/kg/day)

次要结局

  • Infections(up to 1 month)
  • Stool consistency(up to 1 month)
  • Stool frequency(up to 1 month)
  • Growth(28 days)
  • Compliance(28 days)
  • Vomiting(4 weeks)
  • Choking(up to 1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

YogaD

Head of Nutrition and Metabolic Diseases Division Dept of Child Health

Fakultas Kedokteran Universitas Indonesia

研究点 (8)

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