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

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ClinicalTrials.gov Identifier: NCT03842462
Recruitment Status : Not yet recruiting
First Posted : February 15, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Xingwang Zhu, Jiulongpo No.1 People's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Preterm Infant Other: nCPAP Other: NIPPV Other: NHFOV Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 684 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NHFOV vs NIPPV vs nCPAP in Preterm Infants With Respiratory Distress Syndrome: A Multi-center, Prospective, Randomized, Controlled Clinical Superior Trial
Estimated Study Start Date : December 17, 2019
Estimated Primary Completion Date : May 21, 2021
Estimated Study Completion Date : May 21, 2021


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




Primary Outcome Measures :
  1. treatment failure within 72 hours after randomization 72 hours after randomization [ Time Frame: within 72 hours after randomization ]
    need for invasive mechanical ventilation


Secondary Outcome Measures :
  1. 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

  2. Rate of bronchopulmonary dysplasia [ Time Frame: 36 weeks of postmenstrual age ]
    defined according to the NICHD definition

  3. Rate of retinopathy of prematurity (ROP) [ Time Frame: Within 6 months after birth ]
    ≥ 2nd stage

  4. Rate of necrotizing enterocolitis (NEC) [ Time Frame: through study completion, an average of 1 year ]
    ≥ 2nd stage

  5. Rate of intraventricular hemorrhage [ Time Frame: through study completion, an average of 1 year ]
    ≥ 3nd grade


Other Outcome Measures:
  1. Rate of thick secretions causing an airway obstruction. [ Time Frame: during noninvasive respiratory support ]
    determined by the treating clinician by the treating clinician

  2. days of hospitalization [ Time Frame: through study completion, an average of 1 year ]
    days

  3. duration of noninvasive respiratory support [ Time Frame: duration of noninvasive respiratory support ]
    hours

  4. days on supplemental oxygen [ Time Frame: through study completion, an average of 1 year ]
    days

  5. 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

  6. in-hospital mortality [ Time Frame: through study completion, an average of 1 year ]
    Death

  7. Rate of nasal trauma [ Time Frame: through study completion, an average of 1 year ]
    determined by the treating clinician by the treating clinician



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Ages Eligible for Study:   up to 12 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03842462


Contacts
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Contact: Xingwang Zhu, MD 15084335697 15084335697@163.com
Contact: Yuan Shi, PhD 13508300283 petshi530@vip.163.com

Sponsors and Collaborators
Jiulongpo No.1 People's Hospital
Investigators
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Study Chair: Yuan Shi, PhD Children's Hospital of Chongqing Medical University

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Responsible Party: Xingwang Zhu, Doctor, Jiulongpo No.1 People's Hospital
ClinicalTrials.gov Identifier: NCT03842462     History of Changes
Other Study ID Numbers: NHFOV study group
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xingwang Zhu, Jiulongpo No.1 People's Hospital:
Preterm Infant
Respiratory distress syndrome
nasal continuous positive airway pressure
noninvasive intermittent positive airway pressure
noninvasive high-frequency oscillatory ventilation
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Tract Diseases
Infant, Newborn, Diseases
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases