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Ventilation by nasal apparatus in preterm infants

Application of noninvasive positive pressure ventilation after extubation in neonates

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-746nfd
Enrollment
Unknown
Registered
2015-01-15
Start date
2012-08-12
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome Newborn

Interventions

Experimental group: 36 newborns undergoing noninvasive positive pressure ventilation was applied settings on the ventilator (respiratory rate , inspiratory time , positive end-expiratory pressure , in
Device

Sponsors

Universidade Federal de Minas Gerais
Lead Sponsor
Hospital Sofia Feldman
Collaborator

Eligibility

Age
1 Days to 34 Weeks

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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 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 2 hours) in need of oxygen above 50% by use of noninvasive ventilatory support to maintain oxygen saturation in the desired range Outcomes observed: about 80.8% of the sample had successful extubation of newborn infants that failed 70% were male.

Secondary

MeasureTime frame
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 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)

Countries

Brazil

Contacts

Public ContactSimone Ribeiro

Hospital Sofia Feldman

simonensribeiro@hotmail.com+55(31)34082222

Outcome results

None listed

Source: REBEC (via WHO ICTRP)