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N/A N=1,493 Randomized Double-blind Treatment

A Trial Comparing Noninvasive Ventilation Strategies in Preterm Infants Following Extubation

Intubated Infants Were Intend to Extubation Using Noninvasive Ventilation Strategies

Enrolled (actual)
1,493
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Duration of Invasive Mechanical Ventilation — 6.3; 7.8; 7.3 day

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
NHFOV (Device); NCPAP (Device); NIPPV (Device)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Primary completion
May 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Duration of Invasive Mechanical Ventilation
6.3; 7.8; 7.3
PRIMARY
Ventilator-free Days
34; 32; 35
PRIMARY
Number of Babies With Reintubation
63; 123; 84
SECONDARY
Number of Participants With Airleaks
4; 3; 9
SECONDARY
Number of Participants With Bronchopulmonary Dysplasia(BPD)
163; 184; 182
SECONDARY
Number of Participants With Retinopathy of Prematurity> 2nd Stage
63; 74; 72
SECONDARY
Number of Participants With Neonatal Necrotizing Enterocolitis≥ 2nd Stage
33; 24; 36
SECONDARY
Number of Participants With Intraventricular Hemorrhage>2nd Grade
48; 63; 59
SECONDARY
Number of Participants With Need for Postnatal Steroids
63; 77; 98
SECONDARY
In-hospital Mortality
8; 5; 4
SECONDARY
Composite Mortality/BPD
171; 189; 186
SECONDARY
Weekly Weight Gain
13.0; 12.1; 12.4
SECONDARY
Haemodynamically Significant Patent Ductus Arteriosus (PDA)
138; 148; 163

Summary

Respiratory distress syndrome (RDS) is the main cause of respiratory failure in preterm neonates, its incidence varying from 80% to 25% depending on gestational age.When optimal prenatal care is provided, the best approach to treat RDS, according to several recent trials,consists in providing continuous positive airway pressure (CPAP) from the first minutes of life using short binasal prongs or masks, followed by early selective surfactant administration for babies with worsening oxygenation and/or increasing work of breathing. Any effort should be done to minimize the time under invasive mechanical ventilation (IMV).Nonetheless, clinical trials have shown that a relevant proportion of preterm neonates fails this approach and eventually need IMV.The duration of IMV is a well known risk factor for the development of broncho-pulmonary dysplasia (BPD) - a condition associated with significant morbidity and mortality. To minimize the duration of IMV, various non invasive respiratory support modalities are available in neonatal intensive care units (NICU). CPAP is presently the most common technique used in this regard. However, a systematic review has shown that non-invasive positive pressure ventilation (NIPPV) reduces the need for IMV (within one week from extubation) more effectively than NCPAP, although it is not clear if NIPPV may reduce need for intubation longterm and it seems to have no effect on BPD and mortality. NIPPV main drawback is the lack of synchronization, which is difficult to be accurately achieved and is usually unavailable. A more recent alternative technique is non-invasive high frequency oscillatory ventilation (NHFOV) which consists on the application of a bias flow generating a continuous distending positive pressure with oscillations superimposed on spontaneous tidal breathing with no need for synchronization. The physiological, biological and clinical details about NHFOV have been described elsewhere. To date, there is only one small observational uncontrolled study about the use of NHFOV after extubation in preterm infants. Other relatively small case series or retrospective cohort studies suggested safety, feasibility and possible usefulness of NHFOV and have been reviewed elsewhere.The only randomized trial published so far compared NHFOV to biphasic CPAP,in babies failing CPAP and it has been criticized for methodological flaws and for not taking into account respiratory physiology.An European survey showed that, despite the absence of large randomized clinical trials, NHFOV is quite widely used, at least in some Countries and no major side effects are reported, although large data about NHFOV safety are lacking. This may be due to the relative NHFOV easiness of use but evidence-based and physiology-driven data are warranted about this technique.

Eligibility Criteria

Inclusion Criteria

  • gestational age between 25+0 and 32+6 weeks;
  • birth weight more than 600 g;
  • supported with any type of endotracheal ventilation;
  • Has not had first attempt at extubation(extubation readiness requires fulfilling of all the following criteria: a. Having received at least one loading dose of 20 mg/kg and 5 mg/kg daily maintenance dose of caffeine citrate; b. pH>7.20 PaCO2<=60 mmHg (these may be evaluated by arterialized capillary blood gas analysis or appropriately calibrated transcutaneous monitors. Venous blood gas values cannot be used); c. Paw <=7-8 cmH2O; d. FiO2<=0.30; e. sufficient spontaneous breathing effort, as per clinical evaluation).;
  • Obtained parental consent. Informed consent will be obtained antenatally or upon neonatal intensive care unit admission.;

Exclusion Criteria

  • major congenital anomalies or chromosomal abnormalities;
  • Presence of neuromuscular disease;
  • Upper respiratory tract abnormalities; ;
  • need for surgery known before the first extubation;
  • Grade IV-intraventricular haemorrhage (IVH) occurring before the first extubation
  • congenital lung diseases or malformations or pulmonary hypoplasia
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03181958). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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