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临床试验/CTRI/2026/03/105347
CTRI/2026/03/105347尚未招募不适用

Serum Sodium Levels In Healthy Neonates With Excessive Weight Loss In The First Week Of Life A Cross Sectional Observational Study

Kasturba Medical College Manipal1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2026年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
122
试验地点
1

研究概览

简要总结

This is a prospective cross sectional observational study conducted in the Department of Neonatology at a tertiary care teaching hospital. The study aims to evaluate serum sodium levels in healthy late preterm and term breastfed neonates with excessive weight loss during the first postnatal week. Excessive neonatal weight loss is an early indicator of inadequate breastfeeding and may predispose to hypernatremia and dehydration.

Eligible neonates with gestational age greater than 34 weeks and birth weight between 2000 and 4000 grams who are receiving breast milk feeds will be screened by daily weight monitoring from birth until day 7 of life or discharge whichever occurs earlier. Babies with significant weight loss will undergo serum sodium and serum creatinine estimation as per routine unit protocol. No additional blood samples will be collected exclusively for research purposes. Maternal breast milk sodium estimation will be performed through routine laboratory services after obtaining written parental consent.

The primary objective is to determine the incidence of hypernatremia defined as serum sodium greater than or equal to 145 millimoles per liter among neonates with excessive weight loss. Secondary objectives include evaluation of the relationship between neonatal serum sodium levels, maternal breast milk sodium levels, serum creatinine levels, clinical features, and maternal and neonatal risk factors.

The study hypothesis is that excessive neonatal weight loss in the first postnatal week is associated with a higher incidence of hypernatremia and is related to maternal breast milk sodium levels and other clinical variables. The findings may support early identification of at risk neonates and help in developing evidence based screening strategies.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 7.00 Day(s)(—)
性别
All

入选标准

  • Healthy term and late preterm neonates with gestational age greater than or equal to 34 weeks.
  • Birth weight between 2000 and 4000 grams.
  • Receiving exclusively or predominantly breast milk feeds.
  • Neonates with excessive weight loss defined as weight loss greater than or equal to 10 percent of birth weight within the first week of life or greater than or equal to 5 percent within any 24 hour period.

排除标准

  • Major congenital malformations.
  • Formula feed or pasteurized donor human milk feed.
  • Extra mural babies.
  • Multiple gestation.
  • Babies who require more than 1 extra feed within any 24 hour period after inclusion will be censored and removed from the study.

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Riddhi Jain

Kasturba Medical College Manipal Karnataka

研究点 (1)

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