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OpenTrials
Active, Not Recruiting

NCT Number: NCT06327152

Caffeine Use in the Management of Preterm Infants

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Apnea of Prematurity Apnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

1 week–40 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UC Irvine Medical Center

Orange, California, 92868, United States

About this study

This study is a randomized, double-blinded, placebo-controlled trial. Infants will be randomized to receive either caffeine or placebo for up to maximum of four additional weeks after meeting clinical criteria to discontinue caffeine. Initiation of oral feeding will be based on standard of care as determined by a neonatal occupational therapist and clinical cues. Oral feedings will be advanced by a standardized 5 step oral feeding protocol. The time it takes to achieve full oral feeds between the treatment and control groups will be compared.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 2 days (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.

Treatment and study plan

Caffeine

Drug

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.

Sterile Water Placebo

Other

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.

Primary outcomes

  1. Time to full feeds

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

    The primary outcome is time (in days) to full oral bottle feeding or breastfeeding or a combination of both. Full oral bottle feeding is defined as 48 hours of consistent intake of at least 150ml/kg/day of formula or breastmilk. If the subject is on combination of bottle and breastfeeding, two consecutive days of positive weight gain will be used in place of 150ml/kg/day as primary outcome measure.

Secondary outcomes

  1. Time to discharge

    Time frame: Randomization until discharge, up to 6 weeks

    Time to discharge measured in days of hospitalization after randomization

  2. Post menstrual age (PMA) at time of discharge

    Time frame: Randomization until discharge, up to 6 weeks

    Post menstrual age at discharge

  3. Number of significant cardiopulmonary events

    Time frame: Randomization until discharge, up to 6 weeks

    Number of significant cardiopulmonary events defined as apnea > 20 seconds, apnea with heart rate (HR) < 80 beats per minute (bpm), HR < 80 bpm with desaturation < 85% or color change. Significant events are ones that occur while infant is asleep or lying down.

  4. Weight change

    Time frame: Randomization until discharge, up to 6 weeks

    Weight change measured by change in grams

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2024
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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