Trial Outcomes & Findings for NHFOV vs. NCPAP as a Primary Treatment to Neonatal Respiratory Distress Syndrome(NRDS) (NCT NCT03099694)

NCT ID: NCT03099694

Last Updated: 2021-03-02

Results Overview

The criteria for endotracheal mechanical ventilation were as follows: severe respiratory acidosis (PaCO2 \> 60 mmHg with pH\<7.20), severe apnea and bradycardia (defined as recurrent apnea with \> 3 episodes per hour associated with heart rate \< 100/min, a single episode of apnea that required bag and mask ventilation), hypoxia (FiO2\>0.5 with PaO2\<50mmHg), severe respiratory distress, neonatal pulmonary hemorrhage, and cardiopulmonary arrest without effective resuscitation needing continued ventilation and rescue

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 340 participants
• Primary outcome timeframe: during the first 7 days after birth
• Results posted on: 2021-03-02

Participant Flow

From May, 2017, through July, 2018, a total of 18 centers screened 2509 infants, of which 1385 were eligible. We recruited 340 infants (170 in each group), to account for dropouts. Finally, 302 infants completed the trial (152 in NHFOV; 150 in NCPAP group.)

1045 Did not undergo randomization * 663 Refused to participate * 382 NHFOV devices not available

Participant milestones

Measure	nCPAP infants receive primary non-invasive respiratory support by mean of nCPAP	nHFOV infants receive primary non-invasive respiratory support by mean of NHFOV
Overall Study STARTED	170	170
Overall Study COMPLETED	150	152
Overall Study NOT COMPLETED	20	18

Reasons for withdrawal

Measure	nCPAP infants receive primary non-invasive respiratory support by mean of nCPAP	nHFOV infants receive primary non-invasive respiratory support by mean of NHFOV
Overall Study Withdrawal by Subject	11	13
Overall Study Lost to Follow-up	9	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	nCPAP n=150 Participants infants receive primary non-invasive respiratory support by mean of nCPAP	nHFOV n=152 Participants infants receive primary non-invasive respiratory support by mean of NIPPV	Total n=302 Participants Total of all reporting groups
Age, Continuous	30.9 Weeks STANDARD_DEVIATION 1.8 • n=150 Participants	30.6 Weeks STANDARD_DEVIATION 1.7 • n=152 Participants	30.7 Weeks STANDARD_DEVIATION 1.7 • n=302 Participants
Sex: Female, Male Female	71 Participants n=150 Participants	61 Participants n=152 Participants	132 Participants n=302 Participants
Sex: Female, Male Male	79 Participants n=150 Participants	91 Participants n=152 Participants	170 Participants n=302 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Multiple birth	57 Participants n=150 Participants	36 Participants n=152 Participants	93 Participants n=302 Participants
Antenatal steroids	101 Participants n=150 Participants	105 Participants n=152 Participants	206 Participants n=302 Participants
Cesarean delivery	81 Participants n=150 Participants	89 Participants n=152 Participants	170 Participants n=302 Participants
Premature rupture of membranes>18h	61 Participants n=150 Participants	59 Participants n=152 Participants	120 Participants n=302 Participants
Gestational diabetes mellitus	10 Participants n=150 Participants	10 Participants n=152 Participants	20 Participants n=302 Participants
Birth Weight	1582 g STANDARD_DEVIATION 343 • n=150 Participants	1564 g STANDARD_DEVIATION 367 • n=152 Participants	1572 g STANDARD_DEVIATION 351 • n=302 Participants

PRIMARY outcome

Timeframe: during the first 7 days after birth

The criteria for endotracheal mechanical ventilation were as follows: severe respiratory acidosis (PaCO2 > 60 mmHg with pH<7.20), severe apnea and bradycardia (defined as recurrent apnea with > 3 episodes per hour associated with heart rate < 100/min, a single episode of apnea that required bag and mask ventilation), hypoxia (FiO2>0.5 with PaO2<50mmHg), severe respiratory distress, neonatal pulmonary hemorrhage, and cardiopulmonary arrest without effective resuscitation needing continued ventilation and rescue

Outcome measures

Measure	nCPAP n=150 Participants infants receive primary non-invasive respiratory support by mean of nCPAP	nHFOV n=152 Participants infants receive primary non-invasive respiratory support by mean of NHFOV
Number of Participants Who Required Intubation	26 Participants	15 Participants

SECONDARY outcome

Timeframe: first two months after birth

The criteria for intraventricular hemorrhage (IVH, ≥ grade Ⅲ): intraventricular hemorrhage with ventricular dilatation and intraventricular hemorrhage with paren- ehymal hemorrhage. Intraventricular hemorrhage (≥ grade Ⅲ) is worse outcome.

Outcome measures

Measure	nCPAP n=150 Participants infants receive primary non-invasive respiratory support by mean of nCPAP	nHFOV n=152 Participants infants receive primary non-invasive respiratory support by mean of NHFOV
the Incidence of Intraventricular Hemorrhage (IVH, ≥ Grade Ⅲ)	2 Participants	4 Participants

SECONDARY outcome

Timeframe: during non-invasive ventilation, up to 7 days

the incidence of pneumothorax

Outcome measures

Measure	nCPAP n=150 Participants infants receive primary non-invasive respiratory support by mean of nCPAP	nHFOV n=152 Participants infants receive primary non-invasive respiratory support by mean of NHFOV
the Incidence of Pneumothorax	1 Participants	3 Participants

SECONDARY outcome

Timeframe: during non-invasive ventilation, up to 7 days

The criteria for neonatal necrotizing enterocolitis(>stage II): Unequivocal malfunction of the gastrointestinal tract is demonstrated clinically and by radiographic evaluation. Other disorders such as malrotation and volvulus and Hirschsprung's disease must be excluded.

Neonatal necrotizing enterocolitis(>stage II) is worse outcome

Outcome measures

Measure	nCPAP n=150 Participants infants receive primary non-invasive respiratory support by mean of nCPAP	nHFOV n=152 Participants infants receive primary non-invasive respiratory support by mean of NHFOV
the Incidence of Neonatal Necrotizing Enterocolitis(>Stage II)	7 Participants	11 Participants

SECONDARY outcome

Timeframe: at a post-menstrual age of 36 weeks or at discharge

The criteria for Retinopathy of prematurity (>Stage II); extraretinal fibrovascular proliferation neovascularization extends from ridge into the vitreous. Retinopathy of prematurity (>Stage II) is worse outcome.

Outcome measures

Measure	nCPAP n=150 Participants infants receive primary non-invasive respiratory support by mean of nCPAP	nHFOV n=152 Participants infants receive primary non-invasive respiratory support by mean of NHFOV
the Incidence of Retinopathy of Prematurity (>Stage II)	9 Participants	7 Participants

SECONDARY outcome

Timeframe: 30 months

scores of Bayley Scales of Infant Development at 2 months old and 2 years old

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at a post-menstrual age of 36 weeks or at discharge

BPD was defined according to the National Institutes of Health consensus definition: Need for O2 supplementation(FiO2>0.21) for at least 28 days after birth.

BPD is worse outcome.

Outcome measures

Measure	nCPAP n=150 Participants infants receive primary non-invasive respiratory support by mean of nCPAP	nHFOV n=152 Participants infants receive primary non-invasive respiratory support by mean of NHFOV
the Incidence of Bronchopulmonary Dysplasia(BPD)	15 Participants	17 Participants

SECONDARY outcome

Timeframe: during non-invasive ventilation, up to 7 days

Abdominal circumference increase 2 centimeter during non-invasive ventilation

Outcome measures

Measure	nCPAP n=150 Participants infants receive primary non-invasive respiratory support by mean of nCPAP	nHFOV n=152 Participants infants receive primary non-invasive respiratory support by mean of NHFOV
the Incidence of Abdominal Distention	19 Participants	26 Participants

SECONDARY outcome

Timeframe: during non-invasive ventilation, up to 30 days

Hours

Outcome measures

Measure	nCPAP n=150 Participants infants receive primary non-invasive respiratory support by mean of nCPAP	nHFOV n=152 Participants infants receive primary non-invasive respiratory support by mean of NHFOV
The Time of Non-invasive Ventilation	81.0 hours Interval 40.0 to 166.0	78.5 hours Interval 48.0 to 163.5

SECONDARY outcome

Timeframe: during hospitalization, up to 60 days

Days

Outcome measures

Measure	nCPAP n=150 Participants infants receive primary non-invasive respiratory support by mean of nCPAP	nHFOV n=152 Participants infants receive primary non-invasive respiratory support by mean of NHFOV
Length of Hospitalization	29.0 days Interval 19.0 to 41.0	31.0 days Interval 18.5 to 41.0

SECONDARY outcome

Timeframe: during hospitalization, up to 60 days

Outcome measures

Measure	nCPAP n=150 Participants infants receive primary non-invasive respiratory support by mean of nCPAP	nHFOV n=152 Participants infants receive primary non-invasive respiratory support by mean of NHFOV
Predischarge Mortality	4 Participants	6 Participants

SECONDARY outcome

Timeframe: during hospitalization, up to 60 days

Days

Outcome measures

Measure	nCPAP n=150 Participants infants receive primary non-invasive respiratory support by mean of nCPAP	nHFOV n=152 Participants infants receive primary non-invasive respiratory support by mean of NHFOV
Length of O2 Therapy	7.0 days Interval 4.0 to 17.0	8.0 days Interval 4.0 to 17.0

SECONDARY outcome

Timeframe: during non-invasive ventilation, up to 15 days

determined by the clinician

Outcome measures

Measure	nCPAP n=150 Participants infants receive primary non-invasive respiratory support by mean of nCPAP	nHFOV n=152 Participants infants receive primary non-invasive respiratory support by mean of NHFOV
Number of Participants With Thick Secretions Causing an Airway Obstruction	8 Participants	21 Participants

Adverse Events

nHFOV

Serious events: 0 serious events

Other events: 0 other events

Deaths: 6 deaths

nCPAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Shi Yuan

Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, Key Laboratory of Pediatrics in Chongqing

Phone: 13508300283

Email: 15084335697@163.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place