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

NCT ID: NCT06468475

Last Updated: 2024-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Birth Asphyxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Magnesium Sulphate Group

Group Type EXPERIMENTAL

Magnesium Sulphate infusion

Intervention Type 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

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

1 Hour

Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RESnTEC, Institute of Research

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Aamir Latif

Research Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Children's Hospital and the Institute of Child Health

Multan, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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CHMULTAN

Identifier Type: -

Identifier Source: org_study_id

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