NCT02103777

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
Last Updated

April 4, 2014

Status Verified

April 1, 2014

Enrollment Period

2 years

First QC Date

March 27, 2014

Last Update Submit

April 3, 2014

Conditions

ApneaPreterm Infants

Keywords

high dose of caffeinelow dose of caffeineprevention

Outcome Measures

Primary Outcomes (1)

  • Successful extubation from mechanical ventilation

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

    72 hours after extubation from mechanical ventilation

Secondary Outcomes (11)

  • Apnea of prematurity

    Expected average of 8 weeks post natal age

  • Duration of mechanical ventilation and oxygen support

    Expected 4 to 6 weeks postnatal age

  • length of hospital stay

    Expected 8 weeks

  • Neonatal mortality

    Expected 8 weeks

  • Chronic lung disease

    By 36 weeks corrected gestational age

  • +6 more secondary outcomes

Study Arms (2)

High dose caffeine

ACTIVE COMPARATOR

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

Low dose caffeine

ACTIVE COMPARATOR

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

Interventions

Caffeine citrateDRUG

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

High dose caffeineLow dose caffeine

Eligibility Criteria

Age1 Day - 10 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Children Hospital

Al Mansurah, El Dakahlya, 35111, Egypt

Location

MeSH Terms

Conditions

Apnea

Interventions

caffeine citrate

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • sameh m abbas, master

    Mansoura University Children Hospital

    PRINCIPAL INVESTIGATOR

  • nehad a nasef, MD

    Mansoura University Children Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 27, 2014

First Posted

April 4, 2014

Study Start

September 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

April 4, 2014

Record last verified: 2014-04

Locations

EG(1)