NCT03226977

Brief Summary

In the past, several studies have compared the effects between nasal intermittent positive pressure ventilation(NIPPV) and nasal continuous positive airway pressure(NCPAP) on the incidence of intubation in preterm infants, and the results were inconsistent.The purpose of the present study was to compare NIPPV with NCPAP on the need for endotracheal ventilation and subsequent complications

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

July 24, 2017

Status Verified

June 1, 2017

Enrollment Period

3 years

First QC Date

July 12, 2017

Last Update Submit

July 21, 2017

Conditions

Nasal Intermittent Positive Pressure VentilationNasal Continuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

  • intubation rate

    the infant is intubated ventilation

    within 7 days

Secondary Outcomes (4)

  • Intraventricular hemorrhage

    within 28 days

  • bronchopulmonary dysplasia

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

  • Bayley Scales of Infant Development

    at 2 months old and 2 years old

  • Neonatal necrotizing enterocolitis(NEC)

    within 7 days

Study Arms (2)

NIPPV

EXPERIMENTAL

NIPPV is used as a primary mode of ventilation in premature infants with respiratory distress syndrome

Device: NIPPV

NCPAP

ACTIVE COMPARATOR

NCPAP is used as a primary mode of ventilation in premature infants with respiratory distress syndrome

Device: NCPAP

Interventions

NIPPVDEVICE

NIPPV is used as a primary mode of ventilation in premature infants with respiratory distress syndrome

NIPPV
NCPAPDEVICE

NCPAP is used as a primary mode of ventilation in premature infants with respiratory distress syndrome

NCPAP

Eligibility Criteria

Age5 Minutes - 6 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age (GA) is from 26 to 37 weeks;
  • Diagnosis of RDS. The diagnosis of respiratory distress syndrome(RDS) will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings;
  • RDS Silverman score\>5;
  • Informed parental consent has been obtained.

You may not qualify if:

  • Severe RDS requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation;
  • Major congenital malformations or complex congenital heart disease;
  • Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage;
  • Cardiopulmonary arrest needing prolonged resuscitation;
  • Transferred out of the neonatal intensive care unit without treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics, Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

Study Officials

  • Shi Yuan, PhD,MD

    Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

    STUDY DIRECTOR

Central Study Contacts

Ma Juan, MD

CONTACT

13508300283476679422@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 24, 2017

Study Start

August 1, 2017

Primary Completion

July 30, 2020

Study Completion

July 30, 2020

Last Updated

July 24, 2017

Record last verified: 2017-06

Locations

CN(1)