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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01020357




Registration number
NCT01020357
Ethics application status
Date submitted
24/11/2009
Date registered
25/11/2009
Date last updated
5/12/2014

Titles & IDs
Public title
Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study
Scientific title
Long-Term Effects On Sleep Of Methylxanthine Therapy For Apnea Of Prematurity
Secondary ID [1] 0 0
R01HL098045
Secondary ID [2] 0 0
NIH-R01HL098045
Universal Trial Number (UTN)
Trial acronym
CAP-S
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Apnea of Prematurity 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Caffeine citrate injection
Treatment: Drugs - placebo

Active Comparator: caffeine -

Placebo Comparator: placebo -


Treatment: Drugs: Caffeine citrate injection
Loading dose: 20 mg/kg administered over at least 30 minutes via IV infusion or over at least 10 minutes via slow IV injection.
Daily maintenance dose (to commence at least 24 hours after loading dose): 5 mg/kg, administered over at least 10 minutes via IV infusion, or over at least 5 minutes via slow IV injection. Maintenance dose to be adjusted for body weight every 7 days. If indicated, maintenance dose may be increased to a maximum of 10 mg/kg. May be given orally once full enteral feeds are established.
Duration of treatment: discontinue after infant has tolerated at least 5 consecutive days without positive pressure support AND when the infant is judged by the attending clinician to be no longer a candidate for methylxanthine therapy.

Treatment: Drugs: placebo
normal saline
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Aim 1: The primary outcome is the mean actual sleep time as measured by actigraphy, between subjects who received caffeine vs placebo.
Timepoint [1] 0 0
5-7 years
Primary outcome [2] 0 0
Aim 2: The primary outcome is the apnea hypopnea index (AHI) between subjects who received caffeine vs placebo.
Timepoint [2] 0 0
5-7 years
Primary outcome [3] 0 0
Aim 3: The primary outcome is the correlation between full-scale IQ from the Wechsler Preschool and Primary Scale of Intelligence (measured in the CAP trial rather than directly from this protocol), sleep time and AHI.
Timepoint [3] 0 0
5-7 years
Secondary outcome [1] 0 0
Questionnaire data: National Sleep Foundation (NSF) and Pediatric Sleep Questionnaire (PSQ) scores
Timepoint [1] 0 0
5-7 years
Secondary outcome [2] 0 0
Polysomnography data: Sleep architecture, arousal index, central apnea index, SpO2 and periodic limb movement index.
Timepoint [2] 0 0
5-7 years

Eligibility
Key inclusion criteria
- Males or females aged 5-7 years who are enrolled in the CAP trial.

- Parental/guardian permission (informed consent) and if appropriate, child assent.
Minimum age
5 Years
Maximum age
7 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2013
Sample size
Target
Accrual to date
Final
201
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Mercy Hospital for Women - Melbourne
Recruitment hospital [2] 0 0
Royal Women's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
McMaster University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Canadian Institutes of Health Research (CIHR)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
National Heart, Lung, and Blood Institute (NHLBI)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Apnea of prematurity is a common condition that is usually treated with methylxanthines.
Methylxanthines are adenosine receptor blockers that have powerful influences on the central
nervous system. However, little is known about the long-term effects of methylxanthines on
the developing brain.

The Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study is a sub-study of the main Caffeine
for Apnea of Prematurity (CAP) trial, an international placebo-controlled randomized trial of
methylxanthine therapy for apnea of prematurity. This sub-study is designed to take advantage
of this cohort of ex-premature, 5-7 year old children who were randomized at birth to receive
either caffeine or placebo, and are currently receiving detailed neurocognitive and
behavioral assessments in the CAP trial.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01020357
Trial related presentations / publications
Schmidt B, Roberts RS, Davis P, Doyle LW, Barrington KJ, Ohlsson A, Solimano A, Tin W; Caffeine for Apnea of Prematurity Trial Group. Caffeine therapy for apnea of prematurity. N Engl J Med. 2006 May 18;354(20):2112-21. doi: 10.1056/NEJMoa054065.
Schmidt B, Roberts RS, Davis P, Doyle LW, Barrington KJ, Ohlsson A, Solimano A, Tin W; Caffeine for Apnea of Prematurity Trial Group. Long-term effects of caffeine therapy for apnea of prematurity. N Engl J Med. 2007 Nov 8;357(19):1893-902. doi: 10.1056/NEJMoa073679.
Public notes

Contacts
Principal investigator
Name 0 0
Carole Marcus, M.B.B.Ch.
Address 0 0
University of Pennsylvania
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01020357