NCT01875159

Brief Summary

The purpose of this pilot study is to document the extent to which intermittent hypoxia persists beyond the age of discontinuing clinical methylxanthine, and will assess the effect of caffeine treatment on the number of intermittent hypoxia episodes and the total number of seconds with a hemoglobin oxygen saturation (HbO2 SAT) below 90%.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 11, 2013

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 17, 2015

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

1.4 years

First QC Date

June 3, 2013

Results QC Date

January 14, 2014

Last Update Submit

March 16, 2015

Conditions

Hypoxia

Keywords

PrematurityApnea of prematurityIntermittent hypoxia

Outcome Measures

Primary Outcomes (2)

  • Episodes of Intermittent Hypoxia Per Hour

    Number of episodes of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation

    35, 36, 37, 38 weeks postmenstrual age

  • Number of Seconds of Intermittent Hypoxia Per Hour

    Number of seconds of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation

    35, 36, 37, 38 weeks postmenstrual age

Study Arms (2)

Caffeine

EXPERIMENTAL

Caffeine citrate 6 mg/kg/day

Drug: Caffeine citrate 6 mg/kg/day

Active Comparator: no caffeine

NO INTERVENTION

Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.

Interventions

Caffeine citrate 6 mg/kg/dayDRUG

Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age.

Also known as: Cafcit
Caffeine

Eligibility Criteria

Age33 Weeks - 37 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age of 25 + 0 to 32 + 0 weeks PMA at birth, and 34 + 0 to 375 + 6 weeks PMA at randomization
  • Prior treatment with caffeine based on routine clinical indications, and clinical caffeine now discontinued ≥5 days before randomization
  • Previously tolerated clinical treatment with caffeine
  • Breathing room air (no current supplemental O2 treatment; may have previously required respiratory support)
  • Parental consent to enroll in pilot study

You may not qualify if:

  • Congenital syndrome or other medical diagnosis associated with known risk for neurodevelopmental abnormality, including intraventricular hemorrhage Grade 3 or greater, cyanotic congenital heart disease, confirmed central nervous system infection, or fetal alcohol syndrome
  • Currently receiving supplemental oxygen, ventilatory support, or nasal airflow therapy
  • Clinical decision to restart caffeine prior to completing 5 days of continuous physiologic monitoring after clinical caffeine stopped
  • Anticipated inability to meet protocol requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uniformed Services University of Health Sciences

Bethesda, Maryland, 20814, United States

Location

Related Publications (1)

  • Rhein LM, Dobson NR, Darnall RA, Corwin MJ, Heeren TC, Poets CF, McEntire BL, Hunt CE; Caffeine Pilot Study Group. Effects of caffeine on intermittent hypoxia in infants born prematurely: a randomized clinical trial. JAMA Pediatr. 2014 Mar;168(3):250-7. doi: 10.1001/jamapediatrics.2013.4371.

    PMID: 24445955RESULT

MeSH Terms

Conditions

HypoxiaPremature BirthApnea

Interventions

caffeine citrate

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesRespiration DisordersRespiratory Tract Diseases

Results Point of Contact

Title
Carl E. Hunt, M.D.
Organization
Uniformed Services University
carl.hunt@usuhs.edu
240-694-2676

Study Officials

  • Betty McEntire, PhD

    American SIDS Instittute

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor of Pediatrics

Study Record Dates

First Submitted

June 3, 2013

First Posted

June 11, 2013

Study Start

July 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

March 17, 2015

Results First Posted

March 17, 2015

Record last verified: 2015-03

Locations

US(1)