Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573333
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-24
Brief Title:
Effects of Timing of Cord Clamping on Serum Calcium Levels in Neonates
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Timing of Cord Clamping on Serum Calcium Levels in Neonates
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None