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

NCT ID: NCT06573333

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-09-30

Brief Summary

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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

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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.

Conditions

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Serum Calcium Concentration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised Controlled Trails
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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15 seconds

Umbilical Cord will be clamped after 15s of birth and Serum calcium levels will be measured at 6 hours of life

Group Type EXPERIMENTAL

Umblical Cord Clamping

Intervention Type PROCEDURE

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

30seconds

Umbilical Cord will be clamped after 30s of birth and Serum calcium levels will be measured at 6 hours of life

Group Type EXPERIMENTAL

Umblical Cord Clamping

Intervention Type PROCEDURE

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

60seconds

Umbilical Cord will be clamped after 60s of birth and Serum calcium levels will be measured at 6 hours of life

Group Type EXPERIMENTAL

Umblical Cord Clamping

Intervention Type PROCEDURE

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

120 seconds

Umbilical Cord will be clamped after 120s of birth and Serum calcium levels will be measured at 6 hours of life

Group Type EXPERIMENTAL

Umblical Cord Clamping

Intervention Type PROCEDURE

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

Interventions

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Umblical Cord Clamping

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Minute

Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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College of Physicians and Surgeons Pakistan

OTHER

Sponsor Role lead

Responsible Party

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Umair Anees Qureshi

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arshad Khushdil, MBBS

Role: PRINCIPAL_INVESTIGATOR

Military Hospital Rawalpindi

Locations

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Pak Emirates Military Hospital

Rawalpindi, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Umair Qureshi, MBBS

Role: CONTACT

0519273480

Other Identifiers

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369452

Identifier Type: -

Identifier Source: org_study_id

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