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

College of Physicians and Surgeons Pakistan

Status: Enrolling

Conditions: Serum Calcium Concentration

Treatments: Procedure: Umblical Cord Clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT06573333

369452

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 1 minute to 6 hours old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 4 patient groups

15 seconds

Experimental group

Description:

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

Treatment:

Procedure: Umblical Cord Clamping

30seconds

Experimental group

Description:

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

Treatment:

Procedure: Umblical Cord Clamping

60seconds

Experimental group

Description:

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

Treatment:

Procedure: Umblical Cord Clamping

120 seconds

Experimental group

Description:

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

Treatment:

Procedure: Umblical Cord Clamping