N/A
N=410
Monitoring Neonatal Resuscitation Trial
Resuscitation · Neonatal Prematurity · Positive-Pressure Respiration
Bottom Line
View on ClinicalTrials.gov: NCT03256578 ↗Enrolled (actual)
410
Serious AEs
2.4%
Results posted
Jan 2021
Primary outcome: Primary: Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg — 30.2; 30.7 percentage of inflations — p=0.896
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- New Life Box Respiratory Function Monitor (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg |
30.2; 30.7 | 0.896 |
| SECONDARY Percentage of Oxygen Saturation (SpO2) in the First 5 Minutes of Life |
59; 63 | 0.107 |
| SECONDARY Heart Rate in the First 10 Minutes of Life |
144; 143 | 0.847 |
| SECONDARY Percentage of Time With Mask Leak During PPV Ventilation |
17.4; 13.6 | 0.126 |
| SECONDARY Percentage of PPV Inflations With Airway Obstruction |
0; 0 | 0.346 |
| SECONDARY Percentage of PPV Inflations With Inadequate Tidal Volume |
40.7; 34.1 | 0.094 |
| SECONDARY Percentage of Oxygen Saturation (SpO2) in the First 10 Minutes of Life |
84; 85 | 0.656 |
| SECONDARY Fraction of Inspired Oxygen (FiO2) Provided in the First 10 Minutes of Life |
51; 49 | 0.434 |
| SECONDARY Total Duration With FiO2 of 100% Delivered in the First 10 Minutes of Life |
0; 0 | 0.903 |
| SECONDARY Number of Participants Receiving Endotracheal Intubation in the Delivery Room |
47; 54 | 0.699 |
| SECONDARY Number of Participants Requiring Inotropes for Circulatory Support |
22; 32 | 0.231 |
| SECONDARY Number of Participants With Pneumothorax |
6; 11 | 0.283 |
| SECONDARY Number of Participants With Pulmonary Interstitial Emphysema |
12; 7 | 0.168 |
| SECONDARY Number of Participants With Abnormal Cranial Ultrasound Findings |
36; 58 | 0.024 sig |
| SECONDARY Duration of Endotracheal Ventilation |
7; 6 | 0.585 |
| SECONDARY Duration of Non-invasive Ventilation |
41; 37 | 0.342 |
| SECONDARY Duration of Supplemental Oxygen Therapy |
43; 35 | 0.431 |
| SECONDARY Total Duration of Assisted Ventilation |
— | — |
| SECONDARY Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia |
32; 26; 8; 10; 30; 41 | 0.518 |
| SECONDARY Neonatal Mortality |
21; 24 | 0.855 |
| SECONDARY Composite Outcome of Death or BPD |
84; 96 | 0.524 |
| SECONDARY Number of Participants With Retinopathy of Prematurity Requiring Treatment |
9; 15 | 0.280 |
| SECONDARY Number of Participants With a Diagnosis of Necrotizing Enterocolitis |
17; 13 | 0.339 |
| SECONDARY Number of Participants Requiring Fluid Boluses for Circulatory Support |
36; 45 | 0.486 |
| SECONDARY Number of Participants With Endotracheal Intubation in the NICU |
26; 30 | 0.655 |
| SECONDARY Neonatal Mortality in the Delivery Room |
0; 1 | 1.00 |
Summary
This is a randomized trial to determine if a visible respiratory function monitor (RFM) displaying realtime measurements of delivered inflations improves clinical providers ability to perform positive pressure ventilation (PPV) within a pre-defined target tidal volume in preterm infants after birth.
Eligibility Criteria
Inclusion Criteria
- Gestational age (GA) 24 - 27 6/7 weeks at birth, by best obstetrical
- Receive positive pressure ventilation during delivery room resuscitation
Exclusion Criteria
- Known major anomalies including that may affect measured cardiorespiratory parameters: congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease, pulmonary hypoplasia
- RFM not available during resuscitation
Data sourced from ClinicalTrials.gov (NCT03256578). 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.