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CompletedNCT06468475Updated Jun 24, 2024

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

An interventional study of Magnesium Sulphate infusion in Birth Asphyxia, sponsored by RESnTEC, Institute of Research. Completed at 1 site in Pakistan. Open to participants aged 1 Hour to 6 Hours. Per ClinicalTrials.gov, last updated 2024-06-24.

Sponsored by RESnTEC, Institute of Research · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Oct 2023, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
1 Hour to 6 Hours
Sex
All
01

Study summary

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.

02

Conditions studied

  • Birth Asphyxia

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03

In context

Asphyxia Neonatorum

106 studies on the registry are indexed under Asphyxia Neonatorum; 19 are open to participants now.

This study's enrollment of 80 is below the median of 173 across 73 interventional studies indexed under Asphyxia Neonatorum.

Browse Asphyxia Neonatorum studies →

Lead sponsor

RESnTEC, Institute of Research is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Hour to 6 Hours
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Magnesium Sulphate Group

    Drug: Magnesium Sulphate infusion

  • No intervention
    Control

Interventions

  • 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

06

What researchers measure

Primary outcomes

  1. Efficacy

    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.

    Time frame: 72 hours

07

Study locations

1 site
  • The Children's Hospital and the Institute of Child Health
    Multan, Punjab 60000, Pakistan
08

References and documents

Individual participant data

Plan to share: No — Data can be shared with researchers on a reasonable request

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2023 to primary completion in Mar 2024, 5 months.

Of 33 non-industry interventional studies with no phase under Asphyxia Neonatorum, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's 5 months is below that.

Counting every sponsor, half of 33 studies reached it within 15 months; a quarter within 8 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 15, 2024
First posted
Jun 21, 2024
StartActual
Oct 1, 2023
Primary completionActual
Mar 31, 2024
CompletionActual
Mar 31, 2024
Last update
Jun 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06468475
Lead sponsor
RESnTEC, Institute of Research
Responsible party
Muhammad Aamir Latif (Research Consultant, RESnTEC, Institute of Research) — Principal investigator
First posted
Jun 21, 2024
Start date
Oct 1, 2023
Primary completion
Mar 31, 2024
Completion
Mar 31, 2024
Last update
Jun 24, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Magnesium Sulfate

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