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

June 21, 2024 updated by: Muhammad Aamir Latif, RESnTEC, Institute of Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Multan, Punjab, Pakistan, 60000
        • The Children's Hospital and The Institute of Child Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Magnesium Sulphate Group
Drug: Magnesium Sulphate infusion
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: 72 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RESnTEC, Institute of Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

March 31, 2024

Study Registration Dates

First Submitted

June 15, 2024

First Submitted That Met QC Criteria

June 15, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 24, 2024

Last Update Submitted That Met QC Criteria

June 21, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHMultan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data can be shared with researchers on a reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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