Comparison of the effectiveness of maintenance doses of caffeine citrate on tracheal tube removal and apnea after it in premature infants

Phase 2

• Conditions: Tracheal tube extubating and subsequent apnea in premature neonates.; Other apnea of newborn; P28.4

• Registration Number: IRCT20230408057850N1
• Lead Sponsor: Kerman University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Neonates with a gestational age of less than 35 weeks
Hemodynamic stability during the first 48 hours after mechanical ventilation

Exclusion Criteria

Neonates with congenital obstruction and perforation of the gastrointestinal tract
Gastroschisis
Congenital diaphragmatic hernia
Cyanotic heart diseases
Other congenital anomalies

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tracheal extubation failure and subsequent apnea. Timepoint: During the hospitalization period. Method of measurement: Physical examination.

Secondary Outcome Measures

Name	Time	Method
Tachycardia. Timepoint: Duration of treatment. Method of measurement: Cardiac monitoring.;Nutritional intolerance. Timepoint: Duration of treatment. Method of measurement: Physical examination.;Apnea of prematurity. Timepoint: Before and the end of the intervention. Method of measurement: Physical examination.;Duration of use of mechanical ventilation. Timepoint: Before and the end of the intervention. Method of measurement: Based on the questionnaire and file information.;Hospitalization period. Timepoint: Before and the end of the intervention. Method of measurement: Based on the questionnaire and file information.;Necrotizing enterocolitis. Timepoint: Before and the end of the intervention. Method of measurement: Clinical examination and abdominal imaging.;Ductus arteriosus remains open. Timepoint: Before and the end of the intervention. Method of measurement: Clinical examination and echocardiography.