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Completed

NCT Number: NCT01875159

Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm

The purpose of this pilot study is to document the extent to which intermittent hypoxia persists beyond the age of discontinuing clinical methylxanthine, and will assess the effect of caffeine treatment on the number of intermittent hypoxia episodes and the total number of seconds with a hemoglobin oxygen saturation (HbO2 SAT) below 90%.

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Key information

Conditions

Hypoxia Apnea Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Urogenital Diseases

Age range

33 week–37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Uniformed Services University of Health Sciences

Bethesda, Maryland, 20814, United States

About this study

Infants with prior clinical treatment with caffeine in the neonatal intensive care unit (NICU) will be enrolled and continuous physiologic data recording of oxygen hemoglobin saturation (HbO2 SAT) and heart rate will begin as early as 33 weeks postmenstrual age (PMA). Randomization will occur when enrolled infants reach a corrected gestational age of at least 34 weeks PMA AND clinical caffeine has been discontinued for at least 5 days. Infants will be randomized to receive caffeine or to continue with usual care. The group randomized to start caffeine will receive an oral loading dose of caffeine citrate of 20 mg/kg on Day #1, followed by a single daily oral maintenance dose of 6 mg/kg starting on Day #2 and continued daily thereafter until 40 weeks PMA. The continuous oximeter recordings will be stopped at the same time. The number of intermittent hypoxia events/hour per week will be compared between the caffeine group and the usual care (no-caffeine) group for each week of physiologic data recordings.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Gestational age of 25 + 0 to 32 + 0 weeks PMA at birth, and 34 + 0 to 375 + 6 weeks PMA at randomization
  • Prior treatment with caffeine based on routine clinical indications, and clinical caffeine now discontinued ≥5 days before randomization
  • Previously tolerated clinical treatment with caffeine
  • Breathing room air (no current supplemental O2 treatment; may have previously required respiratory support)
  • Parental consent to enroll in pilot study

Exclusion criteria

  • Congenital syndrome or other medical diagnosis associated with known risk for neurodevelopmental abnormality, including intraventricular hemorrhage Grade 3 or greater, cyanotic congenital heart disease, confirmed central nervous system infection, or fetal alcohol syndrome
  • Currently receiving supplemental oxygen, ventilatory support, or nasal airflow therapy
  • Clinical decision to restart caffeine prior to completing 5 days of continuous physiologic monitoring after clinical caffeine stopped
  • Anticipated inability to meet protocol requirements

Treatment and study plan

Caffeine citrate 6 mg/kg/day

Drug

Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age.

Other names: Cafcit

Primary outcomes

  1. Episodes of Intermittent Hypoxia Per Hour

    Time frame: 35, 36, 37, 38 weeks postmenstrual age

    Number of episodes of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation

  2. Number of Seconds of Intermittent Hypoxia Per Hour

    Time frame: 35, 36, 37, 38 weeks postmenstrual age

    Number of seconds of Intermittent hypoxia per hour of pulse oximeter recording less than 90% oxygen saturation

Sponsors and collaborators

Lead sponsor

American SIDS Institute

Other

Registry information

Official study title

Pilot Study of Effects of Caffeine on Intermittent Hypoxia in Infants Born Preterm

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 11, 2013
Registry last updated
Mar 17, 2015

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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