Study Results
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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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2022-08-20
2024-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Melatonin group
Preterm neonates will receive melatonin 30 minutes before the venous cannula insertion.
Melatonin 10 mg
Melatonin 10 mg will be used. 5 mg·kg-1 dissolved in 2 ml of distilled water via enteral route in one single dose 30 minutes before the venous cannula insertion
Placebo group
Preterm neonates will receive 2 ml of distilled water as a placebo 30 minutes before venous cannula insertion.
Placebo
The placebo group will receive 2 ml of distilled water as a placebo 30 minutes before venous cannula insertion.
Interventions
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Melatonin 10 mg
Melatonin 10 mg will be used. 5 mg·kg-1 dissolved in 2 ml of distilled water via enteral route in one single dose 30 minutes before the venous cannula insertion
Placebo
The placebo group will receive 2 ml of distilled water as a placebo 30 minutes before venous cannula insertion.
Eligibility Criteria
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Inclusion Criteria
* less than 37 weeks gestational age
* who started enteral feeding.
Exclusion Criteria
* Facial malformation.
* Receiving analgesia or sedation.
* Contraindication of enteral feeding.
* Clinical or laboratory signs of sepsis.
* Infants with high oxygen needs either on invasive or non-invasive mechanical ventilation.
28 Days
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Locations
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Faculty of Medicine - Ain Shams University
Cairo, , Egypt
Countries
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Other Identifiers
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FMASU MS 496/2022
Identifier Type: -
Identifier Source: org_study_id
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