Clinical trial

Caffeine Use in the Management of Preterm Infants

Name

2659

Description

This study aims to assess whether extending the duration of caffeine therapy will help preterm infants achieve full oral feeding faster.

Trial arms

Trial start

2024-02-22

Estimated PCD

2026-12-31

Trial end

2026-12-31

Status

Recruiting

Phase

Early phase I

Treatment

Caffeine

Infants randomized to receive caffeine will continue to receive caffeine at the current weight-based dose (which is the standard of care maintenance dose of 10-15 mg/kg/day) given every 24 hours. The weight-based dose calculated using the weight at the time of enrollment will be the weight-based dose used for the duration of the study. The dose will be weight adjusted every 7 days, starting on the day of enrollment. Caffeine will be given enterally, via nasogastric tube or by mouth. The study drug (caffeine) will be administered for a maximum of 4 weeks. The study drug will be discontinued after 4 weeks or when the infant reaches Step 4 of our institution's oral feeding protocol (oral feeding 6 times per day), whichever comes first. The study drug will also be discontinued if the open-label maintenance caffeine is started by the clinical team based on clinical indications.

Arms:

Caffeine Group

Sterile Water Placebo

Infants randomized to the placebo group will be given sterile water at an equivalent volume to the volume if caffeine were to be given, using the previous weight-based caffeine dose. The placebo will be given every 24 hours. The dose/volume will be weight adjusted every 7 days, starting on the day of enrollment. The placebo will be given enterally, via nasogastric tube or by mouth. The placebo will be administered for a maximum of 4 weeks. The placebo will be discontinued after 4 weeks or when the infant reaches Step 4 of our institution's oral feeding protocol (oral feeding 6 times per day), whichever comes first. The placebo will also be discontinued if the open-label maintenance caffeine is started by the clinical team based on clinical indications.

Arms:

Placebo Group

Size

Primary endpoint

Time to full feeds

From first nutritive oral feed until full oral feeds achieved, up to 6 weeks

Eligibility criteria

Inclusion Criteria: • Infants born at equal to or less than 32 weeks and 0 days gestational age AND * Equal to or greater than 34 weeks and 0 days corrected gestation at time of enrollment. * Off respiratory support for at least 1 week (nasal canula oxygen, high flow nasal canula, continuous positive airway pressure (CPAP), mechanical ventilation). * On caffeine and meet criteria to discontinue caffeine. * No significant cardiopulmonary events for at least 5 days (apnea \> 20 seconds, apnea with heart rate (HR) \< 80 beats per minute (bpm), HR \< 80 bpm with desaturation \< 85% or color change). Exclusion Criteria: * Infants with critical congenital heart disease. * Infants with neuromuscular conditions affecting respiration. * Infants with overt brain injury (i.e. severe Grade 3-4 intraventricular hemorrhage, cystic periventricular leukomalacia) that may affect oral feeding. * Infants with major genetic disorders. * Infants with anatomic anomalies that will hinder oral feeding. * Infants who have already progressed to Step 3 (of 5) of our institution's oral feeding protocol (oral feeds 4 times per day). * Infants who develop necrotizing enterocolitis after enrollment. * Failure to obtain consent or declined by parents.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized, double-blinded, placebo-controlled trial of 40 preterm infants born at less than or equal to 32 weeks and 0 days gestation. Infants will be randomized to receive either caffeine or placebo for up to maximum of additional four (4) weeks after meeting clinical criteria to come off caffeine.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Families, nurses, therapists, and doctors will be blinded. Only pharmacy will be unblinded and know which subjects are in each treatment arm.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2024-03-26

1 organization

Organization

University of California, Irvine