Enteral and Parenteral Treatment with Caffeine for Preterm Infants in the Delivery Room: A Randomised Trial

Paediatr Drugs. 2023 Jan;25(1):79-86. doi: 10.1007/s40272-022-00541-y. Epub 2022 Oct 27.

Abstract

Background: Early treatment with caffeine in the delivery room (DR) has been proposed to decrease the need for mechanical ventilation (MV) by limiting episodes of apnoea and improving respiratory mechanics in preterm infants. Our aim was to verify the hypothesis that intravenous or enteral administration of caffeine can be performed in the preterm infant in the DR.

Methods: Infants with 25±0-29±6 weeks of gestational age were enrolled and randomised to receive 20 mg/kg of caffeine citrate intravenously, via the umbilical vein, or enterally, through an orogastric tube, within 10 min of birth. Caffeine blood level was measured at 60 ± 15 min after administration and 60 ± 15 min before the next dose (5 mg/kg). The primary endpoint was evaluation of the success rate of intravenous and enteral administration of caffeine in the DR.

Results: Nineteen patients were treated with intravenous caffeine and 19 with enteral caffeine. In all patients the procedure was successfully performed. Peak blood level of caffeine 60 ± 15 min after administration in the DR was found to be below the therapeutic range (5 µg/mL) in 25 % of samples and above the therapeutic range in 3%. Blood level of caffeine 60 ± 15 min before administration of the second dose was found to be below the therapeutic range in 18% of samples.

Conclusions: Intravenous and enteral administration of caffeine can be performed in the DR without interfering with infants' postnatal assistance. Some patients did not reach the therapeutic range, raising the question of which dose is the most effective to prevent MV.

Clinical trial registration: ClinicalTrials.gov identifier NCT04044976; EudraCT number 2018-003626-91.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Apnea / drug therapy
  • Caffeine* / therapeutic use
  • Delivery Rooms
  • Gestational Age
  • Humans
  • Infant, Newborn
  • Infant, Premature*

Substances

  • Caffeine

Associated data

  • ClinicalTrials.gov/NCT04044976