CompletedNot Applicable

Neuroprotective Efficacy of Postnatal Magnesium Sulphate in Term Infants With Birth Asphyxia

Pakistan178 participantsStarted 2023-03-24

Plain-language 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.

Who can participate

Age range

1 Hour – 24 Hours

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

number of participants died (receiving mgso4)

Timeframe: 6 hours

number of participants diednumber (difference in time of administration)

Timeframe: 24 hours

Trial details

NCT IDNCT05707962

SponsorUniversity of Health Sciences Lahore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-24

View on ClinicalTrials.gov More Birth Asphyxia trials