NCT02543125

Brief Summary

To evaluate the efficacy and safety of nasal high frequency oscillatory ventilation(NHFOV) in preterms with respiratory disease syndrome(RDS) after extubation.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

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

August 21, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

6 months

First QC Date

August 21, 2015

Last Update Submit

February 22, 2016

Conditions

Respiratory Insufficiency

Keywords

very low birth weightrespiratory distressNHFOVNIPPV

Outcome Measures

Primary Outcomes (1)

  • intubation rate

    endotracheal intubation rate assessed within 72 hours after extubation

    72 hours

Secondary Outcomes (4)

  • significant apnea

    7 days

  • air leaks

    3 months

  • Bronchopulmonary dysplasia

    3 months

  • necrotizing enterocolitis

    3 months

Study Arms (2)

NIPPV

ACTIVE COMPARATOR

NIPPV is provided via binasal prongs. Ventilator settings:FiO2:21-40%,peak inspiratory pressure( PIP)：12-22cm H2O,positive and expiratory pressure(PEEP):5-7cm H2O,Rate:30-60 per minute to maintain SaO2 at 90-95%,The weaning process is left to the discretion of the attending physician,when FiO2: 25%,mean airway pressure (MAP)\<6cm H2O,R:30 per minute .

Device: NIPPV

NHFOV

ACTIVE COMPARATOR

NHFOV is provided via binasal prongs. Ventilator settings:FiO2:21-40%,MAP：6-14 cm H2O,Hertz(HZ):5-10 to maintain SaO2 at 90-95%,The weaning process is left to the discretion of the attending physician,when FiO2: 25%,mean airway pressure (MAP)\<6cm H2O.

Device: NHFOV

Interventions

NIPPVDEVICE

For infants in the NIPPV-group who "fail"NIPPV (see definition below), need immediate intubation, a invasive "Rescue-Treatment" may be provided. The decision to attempt "Rescue-Treatment", the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician.

Also known as: SLE 5000
NIPPV
NHFOVDEVICE

For infants in the NHFOV-group who "fail"NHFOV (see definition below), need immediate intubation, a invasive "Rescue-Treatment" may be provided. The decision to attempt "Rescue-Treatment", the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician.

Also known as: SLE 5000
NHFOV

Eligibility Criteria

Age1 Hour - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • birth weight\>1000g
  • gestational age \>28 weeks
  • have respiratory distress syndrome and need invasive ventilation

You may not qualify if:

  • birth wight\<1000g
  • gestational age \<28 weeks
  • infants wiht abnormalities of upper and lower airways
  • infants have contraindications of non-invasive ventilation -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Donn SM, Sinha SK. Minimising ventilator induced lung injury in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2006 May;91(3):F226-30. doi: 10.1136/adc.2005.082271.

    PMID: 16632652RESULT

  • van der Hoeven M, Brouwer E, Blanco CE. Nasal high frequency ventilation in neonates with moderate respiratory insufficiency. Arch Dis Child Fetal Neonatal Ed. 1998 Jul;79(1):F61-3. doi: 10.1136/fn.79.1.f61.

    PMID: 9797628RESULT

  • Colaizy TT, Younis UM, Bell EF, Klein JM. Nasal high-frequency ventilation for premature infants. Acta Paediatr. 2008 Nov;97(11):1518-22. doi: 10.1111/j.1651-2227.2008.00900.x. Epub 2008 Jun 9.

    PMID: 18549418RESULT

  • De Luca D, Carnielli VP, Conti G, Piastra M. Noninvasive high frequency oscillatory ventilation through nasal prongs: bench evaluation of efficacy and mechanics. Intensive Care Med. 2010 Dec;36(12):2094-100. doi: 10.1007/s00134-010-2054-7. Epub 2010 Sep 21.

    PMID: 20857278RESULT

  • Null DM, Alvord J, Leavitt W, Wint A, Dahl MJ, Presson AP, Lane RH, DiGeronimo RJ, Yoder BA, Albertine KH. High-frequency nasal ventilation for 21 d maintains gas exchange with lower respiratory pressures and promotes alveolarization in preterm lambs. Pediatr Res. 2014 Apr;75(4):507-16. doi: 10.1038/pr.2013.254. Epub 2013 Dec 30.

    PMID: 24378898RESULT

  • Fischer HS, Bohlin K, Buhrer C, Schmalisch G, Cremer M, Reiss I, Czernik C. Nasal high-frequency oscillation ventilation in neonates: a survey in five European countries. Eur J Pediatr. 2015 Apr;174(4):465-71. doi: 10.1007/s00431-014-2419-y. Epub 2014 Sep 18.

    PMID: 25227281RESULT

MeSH Terms

Conditions

Respiratory InsufficiencyDyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • yang jie, doctor

    Guangdong Women and Children Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 21, 2015

First Posted

September 7, 2015

Study Start

February 1, 2016

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

February 24, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will share