Overview

A Multicentre Double Blind Trial of the Neuroprotective Efficacy of Postnatal Magnesium Sulphate in Term/Near Term Infants With Moderate to Severe Birth Asphyxia

Status:
Not yet recruiting

Trial end date:
2023-08-10

Target enrollment:
0

Participant gender:
All

Summary

Birth/Perinatal asphyxia in Pakistan continues to be a leading cause of neonatal mortality and morbidity. It is estimated that around 80 to 120,000 neonates either suffer from or die from birth/perinatal asphyxia every year. In addition to the large number of deaths a larger number of babies who survive suffer from neuro-developmental disorders adding to the health burden to the society and the nation. To date other than prevention (which requires global efforts to improve maternal education and health care) the therapies available to treat infants who have suffered from birth asphyxia have been either technically too complex or extremely expensive.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Health Sciences Lahore

Treatments:

Magnesium Sulfate
Neuroprotective Agents

Criteria

Inclusion Criteria:

- Term and near term infants (≥35 weeks gestation) with moderate to severe birth
asphyxia Age at admission < 24 hours

Exclusion Criteria:

- Babies who could not be given first injection before 24 hours of age

Infants with major congenital malformations, sepsis, congenital heart defects, Intracranial
hemorrhage and surgical problems

Babies received intubated in emergency

Babies receiving therapeutic hypothermia

Infants with disorders of metabolism

Infants in whom cause other than asphyxia is established as the reason for not initiating
or sustaining breathing at birth.