Caffeine for Apnea of Prematurity-Sleep (CAP-S) Study

NCT01020357 | Completed Phase 3

• 2 other identifiers: NIH-R01HL098045R01HL098045
• Study Type: interventional
• Target: 201
• Locations: 2 countries
• Sites: 4

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.

Conditions

Apnea of Prematurity

Keywords

preterm infants; very low birthweight; apnea of prematurity; methylxanthines; sleep disturbance; obstructive sleep apnea syndrome; polysomnography; sleep disruption

Outcome Measures

Primary Outcomes (3)

• Aim 1: The primary outcome is the mean actual sleep time as measured by actigraphy, between subjects who received caffeine vs placebo.

  5-7 years

• Aim 2: The primary outcome is the apnea hypopnea index (AHI) between subjects who received caffeine vs placebo.

  5-7 years

• 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.

  5-7 years

Secondary Outcomes (2)

• Questionnaire data: National Sleep Foundation (NSF) and Pediatric Sleep Questionnaire (PSQ) scores

  5-7 years

• Polysomnography data: Sleep architecture, arousal index, central apnea index, SpO2 and periodic limb movement index.

  5-7 years

Study Arms (2)

caffeine

ACTIVE COMPARATOR

Drug: Caffeine citrate injection

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Caffeine citrate injection DRUG

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.

Also known as: CafCit

caffeine

placebo DRUG

normal saline

placebo

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males or females aged 5-7 years who are enrolled in the CAP trial.
• Parental/guardian permission (informed consent) and if appropriate, child assent.

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

Mercy Hospital for Women

Melbourne, Australia

Location

Royal Women's Hospital

Melbourne, Australia

Location

McMaster University Medical Centre

Hamilton, Ontario, L8S 4J9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M5S 1B2, Canada

Location

Related Publications (4)

• 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.

  PMID: 16707748 BACKGROUND

• 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.

  PMID: 17989382 BACKGROUND

• Marcus CL, Meltzer LJ, Roberts RS, Traylor J, Dix J, D'ilario J, Asztalos E, Opie G, Doyle LW, Biggs SN, Nixon GM, Narang I, Bhattacharjee R, Davey M, Horne RS, Cheshire M, Gibbons J, Costantini L, Bradford R, Schmidt B; Caffeine for Apnea of Prematurity-Sleep Study. Long-term effects of caffeine therapy for apnea of prematurity on sleep at school age. Am J Respir Crit Care Med. 2014 Oct 1;190(7):791-9. doi: 10.1164/rccm.201406-1092OC.

  PMID: 25171195 RESULT

• Marcus CL, Traylor J, Biggs SN, Roberts RS, Nixon GM, Narang I, Bhattacharjee R, Davey MJ, Horne RS, Cheshire M, Gibbons KJ, Dix J, Asztalos E, Doyle LW, Opie GF, D'ilario J, Costantini L, Bradford R, Schmidt B. Feasibility of comprehensive, unattended ambulatory polysomnography in school-aged children. J Clin Sleep Med. 2014 Aug 15;10(8):913-8. doi: 10.5664/jcsm.3970.

  PMID: 25126039 RESULT

MeSH Terms

Conditions

Apnea; Parasomnias; Sleep Apnea, Obstructive

Interventions

caffeine citrate

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Apnea Syndromes; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Carole Marcus, M.B.B.Ch.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 25, 2009
• Study Start: November 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

AU (2); CA (2)