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Recruiting NCT06573333

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

No phase Interventional Serum Calcium Concentration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Umblical Cord Clamping.
Who it may be relevant to
Registry conditions: Serum Calcium Concentration. Basic parameters: 1 Minute — 6 Hours · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Detailed description

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.

Interventions

  • Procedure Umblical Cord Clamping
    Umbilical Cord will be clamped using a plastic clamp at the noted time after delivery of the neonate

Primary outcome measures

  • Effects of Timing of Cord Clamping on Serum Calcium Levels in Neonates [Time frame: at 6 hours of life]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Pakistan · 1 center
  • Pak Emirates Military Hospital — Rawalpindi

Identifiers

NCT: NCT06573333 · 369452

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗