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Status unknownNCT03226977Updated Jul 24, 2017

Nasal Intermittent Positive Pressure Ventilation(NIPPV) vs Continuous Positive Airway Pressure for Respiratory Distress Syndrome

An interventional study of NIPPV and NCPAP in Nasal Intermittent Positive Pressure Ventilation and Nasal Continuous Positive Airway Pressure, sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University. Status unknown at 1 site in China. Open to participants aged 5 Minutes to 6 Hours. Per ClinicalTrials.gov, last updated 2017-07-24.

Sponsored by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
5 Minutes to 6 Hours
Sex
All
01

Study 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

Read the detailed description

To this day, early use of noninvasive respiratory support strategies has been suggested to be the most effective pathway to reduce those risks. Nasal continuous positive airway pressure (NCPAP) and nasal intermittent positive pressure ventilation (NIPPV) are two widely used ways of noninvasive ventilation strategies in preterm infant. As compared with invasive ventilation, NCPAP reduces the risks abnormal neurodevelopment. However, there is only 60% success rate of avoiding intubation in the preterm neonate supported with NCPAP. Supplying with an intermittent peak pressure on NCPAP, NIPPV is considered as a strengthened version of NCPAP with increased flow delivery in the upper airway, increased minute volume and functional residual capacity and recruitment of collapsed alveoli, improved stability of the chest wall and reduced asynchrony of thoraco-abdominal movement,which have been proven to be crucial to decrease the incidences of invasive ventilation and death. However, 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.

02

Conditions studied

  • Nasal Intermittent Positive Pressure Ventilation
  • Nasal Continuous Positive Airway Pressure
03

In context

Lead sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University is the lead sponsor of 120 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Minutes to 6 Hours
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
1,000 participants (estimated)

Study arms

  • Experimental
    NIPPV

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

    Device: NIPPV

  • Active comparator
    NCPAP

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

    Device: NCPAP

Interventions

  • DeviceNIPPV

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

  • DeviceNCPAP

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

06

What researchers measure

Primary outcomes

  1. intubation rate

    the infant is intubated ventilation

    Time frame: within 7 days

Secondary outcomes

  1. Intraventricular hemorrhage

    the incidence of intraventricular hemorrhage

    Time frame: within 28 days

  2. bronchopulmonary dysplasia

    bronchopulmonary dysplasia was defined according to the National Institutes of Health consensus definition

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

  3. Bayley Scales of Infant Development

    scores of Bayley Scales of Infant Development

    Time frame: at 2 months old and 2 years old

  4. Neonatal necrotizing enterocolitis(NEC)

    the incidence of neonatal necrotizing enterocolitis(\>stage II);for NEC, Bell staging will be used

    Time frame: within 7 days

07

Study locations

1 of 1 sites recruiting
  • Department of Pediatrics, Daping Hospital, Third Military Medical University
    Chongqing, Chongqing Municipality 400042, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2017; primary completion for Jul 2020, 35 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 12, 2017
First posted
Jul 24, 2017
StartEst.
Aug 1, 2017
Primary completionEst.
Jul 30, 2020
CompletionEst.
Jul 30, 2020
Last update
Jul 24, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03226977
Collaborators
Guiyang Maternity and Child Health Care Hospital, Children's Hospital of Chongqing Medical University, Chongqing Maternal and Child Health Hospital, Yan'an Affiliated Hospital of Kunming Medical University, The Children's Hospital of Zhejiang University School of Medicine, Chengdu Women's and Children's Central Hospital, Kunming Children's Hospital, Shanxi Provincial Maternity and Children's Hospital, Children's Hospital of Fudan University, Guangdong Women and Children Hospital, Nanjing Children's Hospital, Jiulongpo No.1 People's Hospital
Responsible party
Ma Juan (Principal Investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University) — Principal investigator
First posted
Jul 24, 2017
Start date
Aug 1, 2017 (estimated)
Primary completion
Jul 30, 2020 (estimated)
Completion
Jul 30, 2020 (estimated)
Last update
Jul 24, 2017

Study contacts

Ma Juan, MD
Contact
476679422@qq.com
13508300283
Shi Yuan, PhD,MD
study director · Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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