Influence of Caffeine Therapy in Preterm Infants

NCT04376749 | Unknown

• 1 other identifier: 09.2019.950
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

caffeine,; sleep wake disorder; preterm; neurodevelopment; actigraphy

Outcome Measures

Primary Outcomes (4)

• Sleep and activity behavior

  Sleep and activity behavior recorded by actigraphy

  6 months corrected age

• Sleep and activity behavior

  Sleep and activity behavior recorded by actigraphy

  12 months corrected age

• Obstructive Apnea and Hypopnea Index

  Obstrcutive Apnea and Hypopnea Index recorded by Polysomnography

  6 months corrected age

• Obstructive Apnea and Hypopnea Index

  Obstrcutive Apnea and Hypopnea Index recorded by Polysomnography

  12 months corrected age

Secondary Outcomes (3)

• Neurodevelopment

  6 and 12 months corrected age

• Neurodevelopment

  6 and 12 months corrected age

• Neurodevelopment

  6 and 12 months corrected age

Study Arms (2)

preterm infants received caffeine

preterm infants aged between 28 to 34 weeks gestational age who received caffeine therapy either for prophylaxis or treatment

preterm infants received no caffeine

preterm infants aged between 28 to 34 weeks gestational age who received no caffeine therapy

Eligibility Criteria

• Age: 28 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Preterm infants born between 28 to 34 gestational weeks admitted to the Marmara University Neonatal Intensive Care Unit (NICU) during one year period

You may qualify if:

• Preterm infants born between 28 to 34 gestational weeks admitted to the Marmara University Neonatal Intensive Care Unit (NICU)

You may not qualify if:

• perinatal asphyxia intraventricular hemorrhage grade 3 or higher retinopathy of prematurity(ROP) of stage 3 or higher major congenital anomalies infants using sedative or anticonvulsant drugs at the time of data collection

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Atalah YEY, Baris HE, Akdere SK, Sabanci M, Ozdemir H, Gucuyener K, Eralp EE, Ozek E, Boran P. Effects of caffeine therapy for apnea of prematurity on sleep and neurodevelopment of preterm infants at 6 months of corrected age. J Clin Sleep Med. 2023 Dec 1;19(12):2075-2085. doi: 10.5664/jcsm.10760.

  PMID: 37559530 DERIVED

MeSH Terms

Conditions

Sleep Wake Disorders; Premature Birth

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Perran Boran, MD, PhD

  Marmara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Perran Boran, MD, PhD

CONTACT

+905417127756; drperran@yahoo.com

Eren Özek, MD

CONTACT

+905324237568; ozekeren@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2020
• First Posted: May 6, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 6, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)