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Completed

NCT Number: NCT06468475

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

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.

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Key information

Conditions

Birth Asphyxia Asphyxia Neonatorum Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases

Age range

1 hour–6 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital and the Institute of Child Health

Multan, Punjab Province, 60000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

RESnTEC, Institute of Research

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 21, 2024
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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