Ventilation by nasal apparatus in preterm infants

Not Applicable

• Conditions: Respiratory Distress Syndrome Newborn; C08.381.842

• Registration Number: RBR-746nfd
• Lead Sponsor: niversidade Federal de Minas Gerais

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-15
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Preterm newborns admitted to the Neonatal Intensive Care Unit of the Hospital Sofia Feldman, diagnosed with Respiratory Distress Syndrome of the Newborn (characterized by progressive respiratory failure after birth), gestational age less than or equal to 34 weeks and weights of the 500 grams less than or equal to 1500 grams classified as appropriate for gestational age, requiring ventilatory support after extubation

Exclusion Criteria

Newborns with congenital anomalies that compromise the cardiorespiratory system, genetic disorders, neuromuscular disease, malformations of the central nervous system

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome in this study was to evaluate the need for intubation within the first 48 hours after extubation in the first three groups and the success rate. A failure extubation observed via clinical judging team with basis following parameters respiratory acidosis pH <7.25 and partial press carbonic Gas at arterial> 65 mmHg; the mean number of apneas (> 6 in 6 hours); episode of apnea, which is characterized by cessation of breathing for 20 seconds associated with central or peripheral cyanosis and bradycardia - heart rate <100 bpm) that does not return with stimulus and indicate reanimation and / or tracheal intubation, constantly evaluated by the medical staff; consistent increase (> 2 hours) in need of oxygen above 50% by use of noninvasive ventilatory support to maintain oxygen saturation in the desired range<br>Outcomes observed: about 80.8% of the sample had successful extubation of newborn infants that failed 70% were male.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes were related to noninvasive support and correlations with sex, gestational age, total duration of oxygen use, total duration of mechanical ventilation and bronchopulmonary dysplasia. Another review was done regarding the failure vs. success, with the days of supplemental oxygen, pulmonary ventilation and occurrence of bronchopulmonary dysplasia. Other outcomes included incidence of pneumothorax, patent ductus arteriosus, high oxygen pressure, peri-intraventricular hemorrhage, bronchopulmonary dysplasia, necrotizing enterocolitis, nasal injury, hospitalization duration, total days on oxygen, total days of mechanical ventilation and death . The newborns were followed until hospital discharge<br>Observed outcomes: newborns who failed (19.2%) had a higher incidence of bronchopulmonary dysplasia (p <0.04) and longer duration of oxygen use (p <0.01)