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

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ClinicalTrials.gov Identifier: NCT03226977
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : July 24, 2017
Sponsor:
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
Information provided by (Responsible Party):
Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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

Condition or disease Intervention/treatment Phase
Nasal Intermittent Positive Pressure Ventilation Nasal Continuous Positive Airway Pressure Device: NIPPV Device: NCPAP Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nasal Intermittent Positive Pressure Ventilation vs Continuous Positive Airway Pressure for Preterm Infants With Respiratory Distress Syndrome:a Multicenter Randomized Controlled Study
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : July 30, 2020


Arm Intervention/treatment
Experimental: NIPPV
NIPPV is used as a primary mode of ventilation in premature infants with respiratory distress syndrome
Device: NIPPV
NIPPV is used as a primary mode of ventilation in premature infants with respiratory distress syndrome

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




Primary Outcome Measures :
  1. intubation rate [ Time Frame: within 7 days ]
    the infant is intubated ventilation


Secondary Outcome Measures :
  1. Intraventricular hemorrhage [ Time Frame: within 28 days ]
    the incidence of intraventricular hemorrhage

  2. bronchopulmonary dysplasia [ Time Frame: at a post-menstrual age of 36 weeks or at discharge ]
    bronchopulmonary dysplasia was defined according to the National Institutes of Health consensus definition

  3. Bayley Scales of Infant Development [ Time Frame: at 2 months old and 2 years old ]
    scores of Bayley Scales of Infant Development

  4. Neonatal necrotizing enterocolitis(NEC) [ Time Frame: within 7 days ]
    the incidence of neonatal necrotizing enterocolitis(>stage II);for NEC, Bell staging will be used



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Ages Eligible for Study:   up to 6 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226977


Contacts
Contact: Ma Juan, MD 13508300283 476679422@qq.com

Locations
China, Chongqing
Department of Pediatrics, Daping Hospital, Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400042
Contact: Juan Ma, physician    18680887330    zoe330@163.com   
Sponsors and Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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
Investigators
Study Director: Shi Yuan, PhD,MD Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Responsible Party: Ma Juan, Principal Investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier: NCT03226977     History of Changes
Other Study ID Numbers: NIPPV of multicenter
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases