Phase 3
N=1,032
Newborn Ventilation in the Delivery Room: Could it be Improved With a T-piece Resuscitator?
Resuscitation
Bottom Line
View on ClinicalTrials.gov: NCT00443118 ↗Enrolled (actual)
1,032
Serious AEs
2.5%
Results posted
Mar 2015
Primary outcome: Primary: Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life. — 93.7; 88; 93 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- T-piece resuscitator Neopuff TM (Device); Self Inflating Bag with PEEP (Device); Self Inflating Bag without PEEP (Device)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Edgardo Szyld
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life. |
93.7; 88; 93 | — |
| SECONDARY Time the Newborn Takes to Reach a HR > 100 Bpm |
1; 1; 1 | — |
| SECONDARY • SpO2 Value at 2 Minutes of Life. |
82; 80; 77 | — |
| SECONDARY • Proportion of Eligible Newborns Who Entered the Study and Who Were Intubated After Failure of PPV With Mask. |
17; 28; 23 | — |
| SECONDARY • Need for Chest Compression and/or Medications |
8; 11; 6 | — |
| SECONDARY Apgar Scores at 1 and 5 Minutes |
153; 111; 66; 30; 24; 23 | — |
| SECONDARY • Incidence of Neonatal Encephalopathy During First Week of Life (Classified by Sarnat) |
21; 21; 7 | — |
| SECONDARY • Incidence of Air Leaks |
13; 6; 2 | — |
| SECONDARY • Use of Oxygen Treatment Beyond the Delivery Room |
208; 126; 96 | — |
| SECONDARY Days on Oxygen |
13.8; 23; 23 | — |
| SECONDARY • Need for Mechanical Ventilation or CPAP |
116; 104; 43 | — |
| SECONDARY Days on Mechanical Ventilation |
5.0; 7; 12 | — |
| SECONDARY Days on CPAP |
7.83; 9.6; 5.2 | — |
| SECONDARY • Incidence of Intracranial Hemorrhage Grades 3-4 for Preterm Newborns <32 Weeks |
10; 1; 3 | — |
Summary
A multicenter cross-over cluster randomized controlled trial protocol study in newborn infants ≥ 26 weeks gestational age requiring assisted ventilation (positive pressure ventilation [PPV]) for resuscitation in the delivery room comparing a T-piece resuscitator device versus resuscitation bag.
Eligibility Criteria
Inclusion criteria
Live-born infants of ≥ 26 weeks' GA with HR < 100 bpm requiring resuscitation with positive pressure ventilation with mask in the delivery room according to the current AAP/AHA recommendations
Exclusion Criteria
Infants requiring intubation from birth. Newborns of < 26 weeks´ GA. Newborns presenting major congenital malformations. Multiple births. Problems (difficulty or malfunctioning) with the device assigned.
Data sourced from ClinicalTrials.gov (NCT00443118). 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.