NHFOV vs NIPPV vs nCPAP in Preterm Infants With Respiratory Distress Syndrome

November 16, 2020 updated by: Xingwang Zhu, Jiulongpo No.1 People's Hospital

NHFOV vs NIPPV vs nCPAP in Preterm Infants With Respiratory Distress Syndrome: A Multi-center, Prospective, Randomized, Controlled Clinical Superior Trial

This will be a prospective, multi-center, three-arms,parallel, randomized, controlled trial with a superiority design,conducted in China. The investigators conduct this multi-centre, randomized, controlled trial to test the hypothesis that NHFOV is more effective than nCPAP or NIPPV in the treatment of respiratory distress syndrome (RDS) in infants with a gestational age of less than 30 weeks or a birth weight of less than 1500g when used as a primary noninvasive ventilation (NIV) mode.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Preterm infants are eligible to the study if they they match the following inclusion criteria: (1) Gestational age (GA) less than 30 weeks or Birth weight less than 1500g; (2) They have a diagnose of RDS, and RDS Silverman score﹥5; (3) Informed parental consent has been obtained.

Neonates will be randomized and assigned either to nCPAP, NIPPV or NHFOV arms with a 1:1:1 ratio, when patients fulfill all inclusion criteria. Randomization cannot be done earlier. Simple randomization will be done according to a computer-generated random number table and will be posted in a specific secured website 24/7 available. Twins will be allocated in the same treatment group. Infants randomized to one arm cannot crossover to the other or vice-versa during the study.

For all the groups, if the fraction of inspired oxygen (FiO2) requirement is persistently higher than 0.35-0.40 per target SpO2 89-94% and/or dyspnoea defined by Silverman score > 6 after starting the respiratory support, newborns receive Surfactant by "INSURE" technique, involving endotracheal intubation by direct laryngoscopic vision, endotracheal administration of surfactant (Curosurf, Chiesi Pharmaceutics, Parma, Italy) 200 mg/kg and finally extubation.

After the administration of surfactant, if FiO2 requirement is persistently >0.4 to keep SpO2 89-94% or severe apnea episodes are present (defined as recurrent apnea with >3 episodes/h associated with heart rate <100/min or a single episode of apnea requiring bag and mask ventilation within a 24-hour period ) or at the blood gas (arterial or free-flowing capillary blood) PaCO2>60 mmHg and potential of hydrogen (pH)<7.20 obtained at least 1 hour after commencement of the assigned treatment, newborns are intubated and mechanically ventilated. For all the newborns enrolled in the study, arterial or free-flowing capillary blood gas is checked every 6-12 hours, a cerebral and cardiac ultrasound screening is performed within 24 hrs. Further controls follow the routine of the ward.

The study intervention (nCPAP, NIPPV or NHFOV) will be stopped when the above-described minimum parameters are reached and maintained for at least 48h with the following: (1) FiO2≤0.25; (2) Silverman score <3; (3)no apneas or bradycardia without spontaneous recovery.If a baby will desaturate (SpO2<85% with FiO2>25%) or has relevant dyspnea (Silverman≧3) or more than 3 apneas/d, the intervention (CPAP, NIPPV or NHFOV) will be restarted for at least 48h and then re-evaluated

Study Type

Interventional

Enrollment (Anticipated)

684

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Recruiting
        • Children's Hospital of Chongqing Medical University
        • Contact:
      • Chongqing, Chongqing, China, 404100
        • Recruiting
        • Chongqing Three Gorges Central Hospital
        • Contact:
      • Chongqing, Chongqing, China, 401120
        • Recruiting
        • Chongqing Women and Children Health Hospital
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550000
        • Recruiting
        • Guiyang Maternity and Child Health Care Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Zhengzhou Children'S Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • Hunan Children's Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • Chengdu Women and Children's Central Hospital
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650000
        • Recruiting
        • Kunming Children's Hospital, Kunming
        • Contact:
          • Yangfang Li, MD
          • Phone Number: 0871-63309191
          • Email: lyf61@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 12 hours (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gestational age (GA) of less than 30 weeks or birth weight less than 1500g
  • Clinical diagnose of RDS
  • Parental consent

Exclusion Criteria:

  • Intubated for resuscitation or for other reasons at birth
  • Major congenital malformations or known complex congenital heart disease
  • No parental consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: nCPAP
neonates assigned to the nCPAP group will be started on a pressure of 6 cmH2O( adjust range:6-8 cmH2O) by pure CPAP system , with FiO2 (0.21～0.40)adjusted to target SpO2 from 89% to 94%
Other: nCPAP
infants receive primary non-invasive respiratory support by mean of nCPAP
ACTIVE_COMPARATOR: NIPPV
neonates assigned to the NIPPV group will be started with the following parameters: a) positive end-expiratory pressure (PEEP) of 4 cmH2O (can be raised in steps of 1 cmH2O to max 8 cmH2O, according to the oxygenation).b)Peak Inspiratory Pressure (PIP) of15 cmH2O (can be raised in steps of 1 cmH2O to max 25 cmH2O, according to oxygenation,PaCO2 levels and the chest expansion); maximal allowed FiO2 will be 0.40 and SpO2 targets will be 90-95%. c) inspiratory time (IT) will be 0.45 - 0.5 sec (according to clinicians'evaluation of leaks and the appearance of the pressure curve: a small pressure plateau is required and flow may be set accordingly) and rate will be started at30 bpm (can be raised in steps of 5 bpm to max 50 bpm, according to PaCO2 levels).
Other: NIPPV
infants receive primary non-invasive respiratory support by mean of NIPPV
EXPERIMENTAL: NHFOV

- neonates assigned to NHFOV will be started with the following boundaries, according to available physiological and mechanical data, as suggested elsewhere:

a) Paw of 10 cmH2O (can be changed in steps of 1 cmH2O within the range range 5- 16cmH2O); Paw will be titrated (within the range) according to open lung strategy, performing alveolar recruitment. Maximal allowed FiO2 will be 0.40 and SpO2 targets will be 89%-94%. b) frequency of 10Hz(can be changed in steps of 1Hz within the range 8-15Hz). c)Inspiratory time 50% (1:1).[ d)amplitude 25 cmH2O(can be changed in steps of 5 cmH2O within the range 25-50 cmH2O); amplitude will be titrated according to PaCO2.
Other: NHFOV
infants receive primary non-invasive respiratory support by mean of NHFOV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment failure within 72 hours after randomization 72 hours after randomization
Time Frame: within 72 hours after randomization
need for invasive mechanical ventilation
within 72 hours after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of bronchopulmonary dysplasia
Time Frame: 36 weeks of postmenstrual age
defined according to the NICHD definition
36 weeks of postmenstrual age
Rate of airleaks(pneumothorax and/or pneumomediastinum) occurred during noninvasive respiratory support
Time Frame: during noninvasive respiratory support
determined by the treating clinician by the treating clinician
during noninvasive respiratory support
Rate of retinopathy of prematurity (ROP)
Time Frame: Within 6 months after birth
≥ 2nd stage
Within 6 months after birth
Rate of necrotizing enterocolitis (NEC)
Time Frame: through study completion, an average of 1 year
≥ 2nd stage
through study completion, an average of 1 year
Rate of intraventricular hemorrhage
Time Frame: through study completion, an average of 1 year
≥ 3nd grade
through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of thick secretions causing an airway obstruction.
Time Frame: during noninvasive respiratory support
determined by the treating clinician by the treating clinician
during noninvasive respiratory support
days of hospitalization
Time Frame: through study completion, an average of 1 year
days
through study completion, an average of 1 year
duration of noninvasive respiratory support
Time Frame: duration of noninvasive respiratory support
hours
duration of noninvasive respiratory support
days on supplemental oxygen
Time Frame: through study completion, an average of 1 year
days
through study completion, an average of 1 year
need for surfactant and caffeine treatment
Time Frame: through study completion, an average of 1 year
determined by the treating clinician by the treating clinician
through study completion, an average of 1 year
in-hospital mortality
Time Frame: through study completion, an average of 1 year
Death
through study completion, an average of 1 year
Rate of nasal trauma
Time Frame: through study completion, an average of 1 year
determined by the treating clinician by the treating clinician
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiulongpo No.1 People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2020

Primary Completion (ANTICIPATED)

May 21, 2022

Study Completion (ANTICIPATED)

May 21, 2022

Study Registration Dates

First Submitted

January 31, 2019

First Submitted That Met QC Criteria

February 14, 2019

First Posted (ACTUAL)

February 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHFOV study group

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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