reduction of breathing spells in preterm infants: air flow versus caffeine

• Conditions: Apnea Of Prematurity; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2013-005568-24-NL
• Lead Sponsor: Medisch Spectrum Twente

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-28
• Last Update Posted: 10 June 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Preterm infants admitted to the department of neonatology are eligible for the study if they are born between 32 and 36 weeks of gestational age, are considered clinically stable off CPAP and if they experience either 4 or more apneic spells in 3 hours; 4 apneic spells in 12 hours or less or 8 apneic spells in 24 hours or less during the first 10 days after birth.
Are the trial subjects under 18? yes
Number of subjects for this age range: 290
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- If other forms of ventilation or continues positive airway pressure is required;
- If apneic spells are due to other causes of apnea than Apnea of Prematurity, such as infection, metabolic disturbances, respiratory compromise, cardiovascular disturbances, central nervous system abnormalities, hematologic imbalance, gastrointestinal abnormalities, disturbance in thermoregulation, or side effects of medication;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified