Preterm InfantNCT03842462
NHFOV vs NIPPV vs nCPAP in Preterm Infants With Respiratory Distress Syndrome
A study testing nCPAP, NIPPV and NHFOV in people with Preterm Infant, run by Jiulongpo No.1 People's Hospital at 8 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 12 hours
- Conditions the study is for
- Preterm Infant
- What is being tested?
- nCPAP, NIPPV and NHFOV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 684 participants
- Where
- 8 sitesChina
- Study dates
- 1 Nov 2020to 21 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age (GA) of less than 30 weeks or birth weight less than 1500g
- Clinical diagnose of RDS
- Parental consent
Who cannot join
- Intubated for resuscitation or for other reasons at birth
- Major congenital malformations or known complex congenital heart disease
- No parental consent
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Not yet recruiting
Hunan Children's Hospital
Changsha, Hunan, 410000
Xirong Gao, MD, 0731-85356114, gaoxirong@126.com
- Recruiting
Chengdu Women and Children's Central Hospital
Chengdu, Sichuan, 610000
Rong Ju, MD, 028-65021687, jurong123@126.com
- Recruiting
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400042
Lei Bao, MD, +8618623298567, cqbl0046@163.com
- Recruiting
Chongqing Women and Children Health Hospital
Chongqing, Chongqing Municipality, 401120
Xiaoyun Zhong, MD, +8613883519380, 13883519380@163.com
- Recruiting
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, 404100
Ming Yi, MD, +8615178969566, yimingd123@126.com
- Recruiting
Guiyang Maternity and Child Health Care Hospital
Guiyang, Guizhou, 550000
Ling Liu, PhD, 0851-5965786, liulingped@sina.com
- Recruiting
Kunming Children's Hospital, Kunming
Kunming, Yunnan, 650000
Yangfang Li, MD, 0871-63309191, lyf61@126.com
- Recruiting
Zhengzhou Children's Hospital
Zhengzhou, Henan, 450000
Huiqing Sun, MD, 0371-85515555, s_huiqing@sina.com
About this study
Official title: 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.
Read the 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
- Conditions
- Preterm Infant
- Being tested
- nCPAP, NIPPV, NHFOV
- Keywords
- Preterm Infant, Respiratory distress syndrome, nasal continuous positive airway pressure, noninvasive intermittent positive airway pressure, noninvasive high-frequency oscillatory ventilation
- Medical subject headings
- Premature Birth, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nCPAPOther
infants receive primary non-invasive respiratory support by mean of nCPAP
NIPPVOther
infants receive primary non-invasive respiratory support by mean of NIPPV
NHFOVOther
infants receive primary non-invasive respiratory support by mean of NHFOV
| Study group | Role | What they receive |
|---|---|---|
| nCPAP | Active comparator | 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% Receives: Other: nCPAP |
| NIPPV | Active comparator | 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). Receives: Other: NIPPV |
| NHFOV | Experimental | - 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. Receives: Other: NHFOV |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment failure within 72 hours after randomization 72 hours after randomization
need for invasive mechanical ventilation
Measured: within 72 hours after randomization
Secondary outcomes (5)
Rate of airleaks(pneumothorax and/or pneumomediastinum) occurred during noninvasive respiratory support
determined by the treating clinician by the treating clinician
Measured: during noninvasive respiratory support
Rate of bronchopulmonary dysplasia
defined according to the NICHD definition
Measured: 36 weeks of postmenstrual age
Rate of retinopathy of prematurity (ROP)
≥ 2nd stage
Measured: Within 6 months after birth
Rate of necrotizing enterocolitis (NEC)
≥ 2nd stage
Measured: through study completion, an average of 1 year
Rate of intraventricular hemorrhage
≥ 3nd grade
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Nov 2020
- Primary completion21 May 2022 (estimated)
- Study completion21 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 684 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiulongpo No.1 People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingwang Zhu, Jiulongpo No.1 People's Hospital
- Investigators
- Yuan Shi, PhD, Study chair, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842462
- Sponsor's protocol ID
- NHFOV study group
- Status last verified
- Nov 2020
- First submitted
- 31 Jan 2019
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NHFOV vs NIPPV vs nCPAP in Preterm Infants With Respiratory Distress Syndrome: A Multi-center, Prospective, Randomized, Controlled Clinical Superior Trial
- ClinicalTrials.gov ID
- NCT03842462
- Acronym / sponsor ID
- NHFOV study group
- Conditions
- Preterm Infant
- Keywords
- Preterm Infant, Respiratory distress syndrome, nasal continuous positive airway pressure, noninvasive intermittent positive airway pressure, noninvasive high-frequency oscillatory ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 684 participants (estimated)
- Lead sponsor
- Jiulongpo No.1 People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 21 May 2022 (estimated)
- Study completion
- 21 May 2022 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| nCPAP | Active comparator | Other: nCPAPneonates 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% |
| NIPPV | Active comparator | Other: NIPPVneonates 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). |
| NHFOV | Experimental | Other: 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. |
Who may qualify
- Ages
- Up to 12 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age (GA) of less than 30 weeks or birth weight less than 1500g
- Clinical diagnose of RDS
- Parental consent
Key exclusion criteria (3 listed)
- Intubated for resuscitation or for other reasons at birth
- Major congenital malformations or known complex congenital heart disease
- No parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nCPAPinfants receive primary non-invasive respiratory support by mean of nCPAP | Other | nCPAP |
| NIPPVinfants receive primary non-invasive respiratory support by mean of NIPPV | Other | NIPPV |
| NHFOVinfants receive primary non-invasive respiratory support by mean of NHFOV | Other | NHFOV |
Primary outcome
treatment failure within 72 hours after randomization 72 hours after randomization
Time frame: within 72 hours after randomization
need for invasive mechanical ventilation
5 secondary outcomes
Rate of airleaks(pneumothorax and/or pneumomediastinum) occurred during noninvasive respiratory support
Time frame: during noninvasive respiratory support
Rate of bronchopulmonary dysplasia
Time frame: 36 weeks of postmenstrual age
Rate of retinopathy of prematurity (ROP)
Time frame: Within 6 months after birth
Rate of necrotizing enterocolitis (NEC)
Time frame: through study completion, an average of 1 year
Rate of intraventricular hemorrhage
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuan Shi, PhD study chair
Children's Hospital of Chongqing Medical University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nCPAP, NIPPV and NHFOV in people with Preterm Infant, run by Jiulongpo No.1 People's Hospital at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xingwang Zhu, MD (15084335697, 15084335697@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment failure within 72 hours after randomization 72 hours after randomization (time frame: within 72 hours after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.