Intermittent Hypoxia and Caffeine in Infants Born Preterm

Completed · Phase 2 · Has a placebo group

Conditions studied: Intermittent Hypoxia

In brief

Intermittent Hypoxia and Caffeine in Infants Born Preterm (ICAF) Our proposal will address the critical question: is persisting intermittent hypoxia (IH) in preterm infants associated with biochemical, structural, or functional injury, and is this injury attenuated with extended caffeine treatment? The investigators will study the effects of caffeine on IH in 220 preterm infants born at ≤30 weeks + 6 days gestation. Infants who are currently being treated with routine caffeine, and who meet eligibility criteria, will be enrolled between 32 weeks + 0 days and 36 weeks + 6 days PMA. At enrollment, infants will be started on continuous pulse oximeter recording of O2 saturation and heart rate. If, based on standard clinical criteria, the last dose of routine caffeine is given on or before the day the infant is 36 weeks + 5 days PMA, then on the day following their last dose of routine caffeine treatment, infants will be randomized (110/group) to extended caffeine treatment or placebo. Randomized infants should begin receiving study drug (i.e. 5 mg/kg/of caffeine base, or equal volume of placebo) on the day of randomization, but no later than the third calendar day following the last dose of routine caffeine. Prior to 36 weeks + 0 days PMA, study drug will be given once daily (i.e. 5mg/kg/day) and beginning at 36 weeks + 0 days PMA, study drug will be given twice daily (i.e. 10 mg/kg/day). The last dose of study drug will be given at 42 weeks + 6 days PMA. Pulse oximeter recordings will continue 1 additional week after discontinuing study drug. Two caffeine levels will be obtained, the 1st at one week after beginning study drug, and the 2nd at a target date of 40 weeks + 0 days PMA, but no later than the last day of study drug, whether in hospital or at home. Inflammatory biomarkers will be measured at study enrollment and again at 38 weeks + 0 days PMA, or within 2 calendar days prior to hospital discharge, whichever comes first. Quantitative MRI/MRS should be obtained between study enrollment and 3 calendar days after starting study drug and again at a target date of 43 weeks + 0 days, but no later than 46 weeks + 6 days PMA.

Key facts

Study ID: NCT03321734
Run by: Children's National Research Institute
People needed: 170
Starts: 2019-01-18
Expected to finish: 2023-06-01
Last updated by the study team: 2023-09-01

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male and female infants born preterm at ≤30 weeks + 6 days post menstrual age
Current treatment with routine caffeine
PMA 32 weeks + 0 days - 36 weeks + 6 days
Anticipated last dose of routine caffeine will be by 36 weeks + 5 days
At least 12 hours of breathing room air with no ventilatory support other than on room air nasal air flow therapy regardless of flow rate, or on room air and receiving nasal CPAP, and relapse not anticipated.
Able to tolerate enteral medications
It is feasible to administer the first dose of study drug no later than 36 weeks + 6 days PMA

You may not qualify if…

Intraventricular hemorrhage Grade III-IV or cystic periventricular leukomalacia
Current or prior treatment for seizures
Current or prior treatment for cardiac arrhythmias
Known renal or hepatic dysfunction that in the opinion of the investigator would have a clinically relevant impact on caffeine metabolism
Major malformation, inborn error of metabolism, chromosomal abnormality
Presence of a condition for which survival to discharge unlikely
Social, mental health, logistical or other issues that, in the opinion of the investigator, would impact the ability of the family to complete the study

Where it is running

Loma Linda University Health System — Loma Linda, California, United States
Children's National Medical Center/Children's Research Institute — Washington D.C., District of Columbia, United States
AdventHealth Orlando — Orlando, Florida, United States
Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
Kapiolani Medical Center — Honolulu, Hawaii, United States
University of Kentucky — Lexington, Kentucky, United States
Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
Johns Hopkins — Baltimore, Maryland, United States
Walter Reed National Military Medical Center — Bethesda, Maryland, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
University of Massachusetss — Worcester, Massachusetts, United States
University of Mississippi — Jackson, Mississippi, United States
Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
Cleveland Clinic — Cleveland, Ohio, United States
Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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