Effects of Timing of Cord Clamping on Serum Calcium Levels in Neonates
1 other identifier
interventional
200
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2024
CompletedFirst Submitted
Initial submission to the registry
August 24, 2024
CompletedFirst Posted
Study publicly available on registry
August 27, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedAugust 27, 2024
August 1, 2024
9 months
August 24, 2024
August 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Effects of Timing of Cord Clamping on Serum Calcium Levels in Neonates
Serum Calcium Levels
at 6 hours of life
Study Arms (4)
15 seconds
EXPERIMENTALUmbilical Cord will be clamped after 15s of birth and Serum calcium levels will be measured at 6 hours of life
30seconds
EXPERIMENTALUmbilical Cord will be clamped after 30s of birth and Serum calcium levels will be measured at 6 hours of life
60seconds
EXPERIMENTALUmbilical Cord will be clamped after 60s of birth and Serum calcium levels will be measured at 6 hours of life
120 seconds
EXPERIMENTALUmbilical Cord will be clamped after 120s of birth and Serum calcium levels will be measured at 6 hours of life
Interventions
Umbilical Cord will be clamped using a plastic clamp at the noted time after delivery of the neonate
Eligibility Criteria
You may not qualify if:
- Mothers with evidence of clinical disease (diabetes, preeclampsia, hypertension). Babies with congenital malformations and intrauterine growth restriction.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pak Emirates Military Hospital
Rawalpindi, Punjab Province, 45000, Pakistan
Study Officials
- PRINCIPAL INVESTIGATOR
Arshad Khushdil, MBBS
Military Hospital Rawalpindi
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
August 24, 2024
First Posted
August 27, 2024
Study Start
January 1, 2024
Primary Completion
September 30, 2024
Study Completion
September 30, 2024
Last Updated
August 27, 2024
Record last verified: 2024-08