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High Versus Low Dose of Caffeine for Apnea of Prematurity

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ClinicalTrials.gov Identifier: NCT02103777
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : April 4, 2014
Sponsor:
Information provided by (Responsible Party):
Nehad Nasef, Mansoura University Children Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Apnea Preterm Infants Drug: Caffeine citrate Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: High Versus Low Dose of Caffeine for Apnea of Prematurity: A Double Blind Randomized Control Trial
Study Start Date : September 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Active Comparator: High dose caffeine
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)
Drug: Caffeine citrate
Caffeine will be given by either high dose in Arm 1 or low dose in Arm 2

Active Comparator: Low dose caffeine
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.
Drug: Caffeine citrate
Caffeine will be given by either high dose in Arm 1 or low dose in Arm 2




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   up to 10 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103777


Locations
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Egypt
Mansoura University Children Hospital
Mansoura, El Dakahlya, Egypt, 35111
Sponsors and Collaborators
Mansoura University Children Hospital
Investigators
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Principal Investigator: sameh m abbas, master Mansoura University Children Hospital
Study Director: nehad a nasef, MD Mansoura University Children Hospital

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Responsible Party: Nehad Nasef, Associate Professor, Mansoura University Children Hospital
ClinicalTrials.gov Identifier: NCT02103777     History of Changes
Other Study ID Numbers: NICU MUCH 2013
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: April 4, 2014
Last Verified: April 2014
Keywords provided by Nehad Nasef, Mansoura University Children Hospital:
high dose of caffeine
low dose of caffeine
prevention
Additional relevant MeSH terms:
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Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Caffeine
Caffeine citrate
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents