Enhancing Neonatal Sucking Reflex: A Study on the Efficacy of Magnesium Sulphate in Severe Birth Asphyxia

NCT06468475 | Completed

• 1 other identifier: CHMULTAN
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Children's Hospital Multan is a tertiary care teaching hospital in South Punjab, the poorest and most backward area of Punjab, Pakistan, where a significant number of newborns suffer from birth asphyxia. Therefore, this study was planned with the objective of investigating the effectiveness of magnesium sulphate in severe birth asphyxia, hypothesizing that in cases of birth asphyxia, neonates who are treated with magnesium sulphate have a higher sucking reflex than those who are not treated with magnesium sulphate.

Conditions

Birth Asphyxia

Outcome Measures

Primary Outcomes (1)

• Efficacy

  Efficacy was labeled as yes if the infant was placed in the supine position, the index finger was placed in the infant's mouth, and the power of sucking movements was judged after 5 seconds, and If the sucking reflex appeared. Efficacy was termed no otherwise.

  72 hours

Study Arms (2)

Magnesium Sulphate Group

EXPERIMENTAL

Drug: Magnesium Sulphate infusion

Control

NO INTERVENTION

Interventions

Magnesium Sulphate infusion DRUG

Magnesium sulphate 24 hours apart by intravenous infusion at 250 mg/kg/dose (0.5 mL/kg/dose of injection magnesium sulphate 50% w/v diluted in 5 mL/kg of 5% glucose) over a duration of half an hour by an infusion pump

Magnesium Sulphate Group

Eligibility Criteria

• Age: 1 Hour - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Full-term babies (≥37 weeks of gestation)
• Both genders
• Severe birth asphyxia
• Admitted within six hours of life.

You may not qualify if:

• Premature babies
• Congenital malformations
• Babies born to mothers who received general anesthesia
• Babies whose mothers received magnesium sulfate, pethidine, and other drugs in the past 7 days.

Sponsors & Collaborators

• RESnTEC, Institute of Research: lead

Study Sites (1)

The Children's Hospital and the Institute of Child Health

Multan, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: June 15, 2024
• First Posted: June 21, 2024
• Study Start: October 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)