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

August 24, 2024 updated by: Umair Anees Qureshi, College of Physicians and Surgeons Pakistan

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 45000
        • Recruiting
        • Pak Emirates Military Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 15 seconds
Umbilical Cord will be clamped after 15s of birth and Serum calcium levels will be measured at 6 hours of life
Procedure: Umblical Cord Clamping
Umbilical Cord will be clamped using a plastic clamp at the noted time after delivery of the neonate
Experimental: 30seconds
Umbilical Cord will be clamped after 30s of birth and Serum calcium levels will be measured at 6 hours of life
Procedure: Umblical Cord Clamping
Umbilical Cord will be clamped using a plastic clamp at the noted time after delivery of the neonate
Experimental: 60seconds
Umbilical Cord will be clamped after 60s of birth and Serum calcium levels will be measured at 6 hours of life
Procedure: Umblical Cord Clamping
Umbilical Cord will be clamped using a plastic clamp at the noted time after delivery of the neonate
Experimental: 120 seconds
Umbilical Cord will be clamped after 120s of birth and Serum calcium levels will be measured at 6 hours of life
Procedure: Umblical Cord Clamping
Umbilical Cord will be clamped using a plastic clamp at the noted time after delivery of the neonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of Timing of Cord Clamping on Serum Calcium Levels in Neonates
Time Frame: at 6 hours of life
Serum Calcium Levels
at 6 hours of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

College of Physicians and Surgeons Pakistan

Investigators

  • Principal Investigator: Arshad Khushdil, MBBS, Military Hospital Rawalpindi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

August 24, 2024

First Submitted That Met QC Criteria

August 24, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 24, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 369452

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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