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临床试验/NCT06573333
NCT06573333招募中不适用

Effects of Timing of Cord Clamping on Serum Calcium Levels in Neonates

College of Physicians and Surgeons Pakistan2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
Effects of Timing of Cord Clamping on Serum Calcium Levels in Neonates

研究概览

简要总结

Title: Effect of timing of cord clamping of serum calcium levels in neonates Background: Hypocalcemia is a common metabolic problem in neonatal period. Most cases of hypocalcemia are asymptomatic however, the symptomatic cases require prompt management.

Objective: The objective is to determine the effects of early and delayed cord on serum calcium level in neonates Study Design: Randomized Controlled Trial

详细描述

Place and Duration of Study: PEMH Rawalpindi and CMH Rawalpindi from January 2024 to July 2024.

Patients and Methods: Total sample size of 200 neonates will be included in the study divided into four groups with cord clamping at 15s, 30s, 60s, 120s each group will have a total of 50 neonates. Blood sampling for CBC / CRP / S. Electrolytes (Na, K, Total Ca, Ionized Ca, Mg), S Calcitonin, ABGs (HCO3 Levels) samples will be collected at 6 hours of life.

  • Inclusion Criteria: Neonates born at gestational age 37 weeks to 41 weeks with no maternal complication. Parents who give consent for inclusion in the study
  • Exclusion Criteria: Mothers with evidence of clinical disease (diabetes, preeclampsia, hypertension). Babies with congenital malformations and intrauterine growth restriction.

Expected Results: Research data on serum Calcium levels in neonates have shown no correlation to timing of cord clamping. Same results are expected in this study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
1 Minute 至 6 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates born at gestational age 37 weeks to 41 weeks with no maternal complication. Parents who give consent for inclusion in the study

排除标准

  • Mothers with evidence of clinical disease (diabetes, preeclampsia, hypertension). Babies with congenital malformations and intrauterine growth restriction.

结局指标

主要结局

Effects of Timing of Cord Clamping on Serum Calcium Levels in Neonates

时间窗: at 6 hours of life

Serum Calcium Levels

次要结局

未报告次要终点

研究者

发起方
College of Physicians and Surgeons Pakistan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Umair Anees Qureshi

Doctor

College of Physicians and Surgeons Pakistan

研究点 (2)

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