MedDataX Logo

Nasal Intermittent Positive-Pressure Ventilation for Twin Infants With Respiratory Distress Syndrome

NCT ID: NCT01926106

Last Updated: 2017-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

286 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-01

Study Completion Date

2017-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

After inclusion of eligible twins infants,one of the twins was supported by nCPAP and another nIPPV.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neonatal Respiratory Distress Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Nasal Intermittent Positive-Pressure Ventilation Nasal Continuous Positive Airway Pressure twin respiratory distress syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

nIPPV

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

Group Type EXPERIMENTAL

nIPPV

Intervention Type DEVICE

one of the twins was randomly allocated to nIPPV

nCPAP

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

Group Type ACTIVE_COMPARATOR

nCPAP

Intervention Type DEVICE

another of the twins was allocated to nCPAP

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

nIPPV

one of the twins was randomly allocated to nIPPV

Intervention Type DEVICE

nCPAP

another of the twins was allocated to nCPAP

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

nIPPV:Nasal Intermittent Positive Pressure Ventilation nCPAP:Nasal Continuous Positive Airway Pressure

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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)

Exclusion Criteria

* pneumothorax
* pneumomediastinum
* surgical diseases
* cardiac diseases
* intraventricular hemorrage
* major congenital defects
Minimum Eligible Age

30 Minutes

Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chen Long,MD

Prof;MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Long Chen, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Chongqing, Chongqing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

twins

Identifier Type: -

Identifier Source: org_study_id