Caffeine Use in the Management of Preterm Infants

University of California Irvine (UCI)

Status and phase: Active, not recruiting; Phase 2

Conditions: Apnea of Prematurity

Treatments: Other: Sterile Water Placebo; Drug: Caffeine

Study type: Interventional

Funder types: Other

Identifiers

NCT06327152

2659

Details and patient eligibility

About

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

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 1 to 40 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Caffeine Group

Active Comparator group

Description:

Infants randomized to receive caffeine will continue to receive caffeine at standard of care maintenance dose of 10-15 mg/kg/day given every 24 hours. 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.

Treatment:

Drug: Caffeine

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Other: Sterile Water Placebo