NHFOV vs NIPPV vs nCPAP in Preterm Infants With Respiratory Distress Syndrome
NCT ID: NCT03842462
Last Updated: 2020-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
684 participants
INTERVENTIONAL
2020-11-01
2022-05-21
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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%
nCPAP
infants receive primary non-invasive respiratory support by mean of nCPAP
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).
NIPPV
infants receive primary non-invasive respiratory support by mean of NIPPV
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.
NHFOV
infants receive primary non-invasive respiratory support by mean of NHFOV
Interventions
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nCPAP
infants receive primary non-invasive respiratory support by mean of nCPAP
NIPPV
infants receive primary non-invasive respiratory support by mean of NIPPV
NHFOV
infants receive primary non-invasive respiratory support by mean of NHFOV
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnose of RDS
* Parental consent
Exclusion Criteria
* Major congenital malformations or known complex congenital heart disease
* No parental consent
12 Hours
ALL
No
Sponsors
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Jiulongpo No.1 People's Hospital
OTHER
Responsible Party
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Xingwang Zhu
Doctor
Principal Investigators
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Yuan Shi, PhD
Role: STUDY_CHAIR
Children's Hospital of Chongqing Medical University
Locations
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Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Chongqing Women and Children Health Hospital
Chongqing, Chongqing Municipality, China
Chongqing Three Gorges Central Hospital
Chongqing, Chongqing Municipality, China
Guiyang Maternity and Child Health Care Hospital
Guiyang, Guizhou, China
Zhengzhou Children's Hospital
Zhengzhou, Henan, China
Hunan Children's Hospital
Changsha, Hunan, China
Chengdu Women and Children's Central Hospital
Chengdu, Sichuan, China
Kunming Children's Hospital, Kunming
Kunming, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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Lei Bao, MD
Role: primary
Xiaoyun Zhong, MD
Role: primary
Ming Yi, MD
Role: primary
Ling Liu, PhD
Role: primary
Huiqing Sun, MD
Role: primary
Xirong Gao, MD
Role: primary
Rong Ju, MD
Role: primary
Yangfang Li, MD
Role: primary
Other Identifiers
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NHFOV study group
Identifier Type: -
Identifier Source: org_study_id