Early Versus Routine Caffeine Administration in Extremely Preterm Neonates (EARLYCAFFEINE)

S

Sharp HealthCare

Status and phase

Completed
Phase 4

Conditions

Caffeine

Treatments

Drug: Caffeine

Study type

Interventional

Funder types

Other

Identifiers

NCT01783561
2HRCAFFEINE

Details and patient eligibility

About

Premature infants are at risk of having pauses in breathing, or apneas, due to their immaturity. Premature infants are routinely given caffeine, a respiratory stimulant, on the first day of life to prevent apneas. However, if they continue to have apneas, they may require a breathing tube to be placed in the trachea. There are risks to having a breathing tube, so it would be beneficial to avoid it if possible. If caffeine is given earlier, it may decrease the need for a breathing tube. Some studies also suggest that caffeine may also improve heart function which may prevent low blood pressure if given early.

Full description

This goal of this observational study is to compare the respiratory and acute hemodynamic effects of caffeine administered in the first 2 hours versus 12 hours of life in infants <29 weeks gestation. Our primary hypothesis is that caffeine administered in the first two hours of life can prevent the need for endotracheal intubation in the first 12 hours of life.. These evaluations are critical in determining both the safety and efficacy of early caffeine therapy.

Enrollment

21 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Any infant delivered at Sharp Mary Birch Hospital between 23 and 28 6/7 weeks; gestation

Exclusion criteria

  • Any infant with a major congenital anomaly including airway anomalies, congenital diaphragmatic hernia, or hydrops
  • Any infant with a known or a discovered major cardiac defect other than a patent ductus arterious (PDA), patent foramen ovale (PFO), or small ventricular septal defect (VSD)
  • Inability to place a peripheral IV after two attempts. Severe apnea or bradycardia in the first 60 minutes of life requiring emergent endotracheal intubation.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

21 participants in 2 patient groups, including a placebo group

early caffeine
Active Comparator group
Description:
Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 15 minutes within the first 2 hours of life. If the infant is in the early caffeine group, the blinded drug will be IV caffeine citrate 20mg/kg in the first 2 hours and placebo at 12 hours of life.
Treatment:
Drug: Caffeine
Routine caffeine
Placebo Comparator group
Description:
Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. If the infant is in the routine caffeine group, the blinded drug will be placebo in the DR and IV caffeine citrate 20mg/kg at 12 hours of life.
Treatment:
Drug: Caffeine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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