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Completed

NCT Number: NCT02103777

High Versus Low Dose of Caffeine for Apnea of Prematurity

The optimum caffeine dose for apnea of prematurity has not been well investigated so the objective of the study is to compare high versus low dose of caffeine citrate to facilitate successful extubation in mechanically ventilated preterm infants.

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Key information

Age range

1 day–10 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mansoura University Children Hospital

Al Mansurah, El Dakahlya, 35111, Egypt

About this study

A randomized, double blind, clinical trial which will be conducted in Neonatal Intensive Care Unit, Mansoura University Children Hospital, Egypt on preterm infants born less than 32 weeks gestation mechanically ventilated within the first 10 days of life to study the optimum caffeine dose for apnea of prematurity and compare High dose (loading 40 mg/kg/day equivalent to 20 mg /kg/day of caffeine base and maintenance of 20 mg/kg/day equivalent to 10 mg /kg/day of caffeine base) versus low dose (loading 20 mg/kg/day equivalent to 10 mg /kg/day of caffeine base and maintenance of 10 mg/kg/day equivalent to 5 mg /kg/day of caffeine base) caffeine citrate started within the first 10 days of life and its effect on need of re-intubation within 72 hours of extubation from mechanical ventilation as primary outcome and frequency and duration of apnea, duration of mechanical ventilation and oxygen support, length of hospital stay, neonatal mortality, chronic lung disease, necrotising enterocolitis, intraventricular haemorrhage, periventricular leukomalacia, hydrocephalus, retinopathy of prematurity, and caffeine side effects as secondary outcomes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • newborn infant less than 32 weeks gestation with the diagnosis of apnea

Exclusion criteria

  • newborn infants with gestational age more than 32 weeks.
  • newborn infant with congenital malformations or chromosomal anomalies.

Treatment and study plan

Caffeine citrate

Drug

Caffeine will be given by either high dose in Arm 1 or low dose in Arm 2

Primary outcomes

  1. Successful extubation from mechanical ventilation

    Time frame: 72 hours after extubation from mechanical ventilation

    Need of re-intubation within 72 hours of extubation from mechanical ventilation

Secondary outcomes

  1. Apnea of prematurity

    Time frame: Expected average of 8 weeks post natal age

    Frequency and documented days of apnea

  2. Duration of mechanical ventilation and oxygen support

    Time frame: Expected 4 to 6 weeks postnatal age

  3. length of hospital stay

    Time frame: Expected 8 weeks

  4. Neonatal mortality

    Time frame: Expected 8 weeks

    Death before hospital discharge

  5. Chronic lung disease

    Time frame: By 36 weeks corrected gestational age

    Need for oxygen by 36 weeks corrected gestational age

  6. Necrotising enterocolitis

    Time frame: Expected 6 weeks

  7. Intraventricular haemorrhage

    Time frame: Expected 2 weeks

  8. Periventricular leukomalacia

    Time frame: Expected 8 weeks

  9. Hydrocephalus

    Time frame: Expected 8 weeks

  10. Retinopathy of prematurity

    Time frame: Expected 8 weeks

  11. Caffeine side effects.

    Time frame: Expected 6 weeks

Sponsors and collaborators

Lead sponsor

Mansoura University Children Hospital

Other

Registry information

Official study title

High Versus Low Dose of Caffeine for Apnea of Prematurity: A Double Blind Randomized Control Trial

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 4, 2014
Registry last updated
Apr 4, 2014

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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