NCT01926106

Brief Summary

In the present study, we hypothesized that primary mode nIPPV initiated shortly after birth would decrease the incidence of intubation or death in twin infants when compared to nCPAP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
286

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 20, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2017

Completed
Last Updated

December 7, 2017

Status Verified

August 1, 2013

Enrollment Period

5.1 years

First QC Date

August 8, 2013

Last Update Submit

December 6, 2017

Conditions

Neonatal Respiratory Distress Syndrome

Keywords

Nasal Intermittent Positive-Pressure VentilationNasal Continuous Positive Airway Pressuretwinrespiratory distress syndrome

Outcome Measures

Primary Outcomes (1)

  • incidence of intubation

    48h

Secondary Outcomes (1)

  • incidence of BPD

    1 month

Other Outcomes (1)

  • death

    3 months

Study Arms (2)

nIPPV

EXPERIMENTAL

the infants in the arm were supported by Nasal Intermittent Positive-Pressure Ventilation(nIPPV)

Device: nIPPV

nCPAP

ACTIVE COMPARATOR

the infants in the arm were supported by Nasal Continuous Positive Airway Pressure(nCPAP)

Device: nCPAP

Interventions

nIPPVDEVICE

one of the twins was randomly allocated to nIPPV

Also known as: nIPPV:Nasal Intermittent Positive Pressure Ventilation
nIPPV
nCPAPDEVICE

another of the twins was allocated to nCPAP

Also known as: nCPAP:Nasal Continuous Positive Airway Pressure
nCPAP

Eligibility Criteria

Age30 Minutes - 6 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Twins
  • Clinical diagnosis of mild-moderate respiratory distress syndrome
  • requiring a fraction of inspired oxigen (FiO2 ) \<0.40 to keep oxygen saturation of 90%-95%
  • a chest X-ray suggestive of early stage hyaline membrane disease, (i.e. mild microgranulia and air bronchogram)

You may not qualify if:

  • pneumothorax
  • pneumomediastinum
  • surgical diseases
  • cardiac diseases
  • intraventricular hemorrage
  • major congenital defects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome, NewbornRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Long Chen, MD

    Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University,

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 8, 2013

First Posted

August 20, 2013

Study Start

July 1, 2012

Primary Completion

July 30, 2017

Study Completion

July 30, 2017

Last Updated

December 7, 2017

Record last verified: 2013-08

Locations

CN(1)