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Influence of Caffeine Therapy in Preterm Infants

NCT04376749 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2020-05-06

No results posted yet for this study

Summary

The development of sleep wake cycles is indicative of child's neurocognitive functions. Caffeine therapy is commonly used in neonatal intensive care units for treatment of apnea of prematurity (AOP), to reduce mechanical ventilation, and improve the success of extubation. In addition, it is suggested to be associated with positive long-term outcomes on pulmonary function and neurodevelopment. However, it is still not clear how caffeine therapy affects the sleep architecture and neurodevelopment of preterm infants. Furthermore, optimal dosing and timing of caffeine therapy is controversial.

We aimed to evaluate the effects of caffeine therapy on sleep architecture and neurodevelopment in preterm infants during the first year of life.

A prospective observational case-control study will be conducted. Forty preterm infants aged between 28 to 34 gestational weeks admitted to the Marmara University Neonatal Intensive Care Unit (NICU) from May 2020 to May 2021 will be included. Infants with neonatal risk factors for poor neurodevelopmental outcomes will be excluded. Duration, timing and cumulative dosage of caffeine therapy will be calculated. Follow up outcome for neurodevelopment and sleep architecture of preterm infants who received caffeine therapy will be compared with those who did not receive caffeine therapy.

Sleep and activity behavior recorded by actigraphy, sleep diary and polysomnography at 6, and 12 months corrected age will be compared to noncaffeine group. Neurodevelopment will be assessed by neurological examination defined by Hammersmith, Ages and Stages Questionnaire (ASQ-2), and Bayley Scales of Infant and Toddler Development.

Conditions

  • Caffeine; Sleep Disorder

Sponsors & Collaborators

  • Marmara University

    lead OTHER

Principal Investigators

  • Perran Boran, MD, PhD · Marmara University

Eligibility

Min Age
28 Weeks
Max Age
34 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-31
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04376749 on ClinicalTrials.gov