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

Preterm Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03842462
• Other study ID #: NHFOV study group
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: May 21, 2022

Study information

• Verified date: November 2020
• Source: Jiulongpo No.1 People's Hospital
• Contact: Xingwang Zhu, MD
• Phone: 15084335697
• Email: 15084335697[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 684
• Est. completion date: May 21, 2022
• Est. primary completion date: May 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Hours

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infant
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Other:
• 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

Locations

Country	Name	City	State
China	Hunan Children's Hospital	Changsha	Hunan
China	Chengdu Women and Children's Central Hospital	Chengdu	Sichuan
China	Children's Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Chongqing Three Gorges Central Hospital	Chongqing	Chongqing
China	Chongqing Women and Children Health Hospital	Chongqing	Chongqing
China	Guiyang Maternity and Child Health Care Hospital	Guiyang	Guizhou
China	Kunming Children's Hospital, Kunming	Kunming	Yunnan
China	Zhengzhou Children's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Jiulongpo No.1 People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of thick secretions causing an airway obstruction.	determined by the treating clinician by the treating clinician	during noninvasive respiratory support
Other	days of hospitalization	days	through study completion, an average of 1 year
Other	duration of noninvasive respiratory support	hours	duration of noninvasive respiratory support
Other	days on supplemental oxygen	days	through study completion, an average of 1 year
Other	need for surfactant and caffeine treatment	determined by the treating clinician by the treating clinician	through study completion, an average of 1 year
Other	in-hospital mortality	Death	through study completion, an average of 1 year
Other	Rate of nasal trauma	determined by the treating clinician by the treating clinician	through study completion, an average of 1 year
Primary	treatment failure within 72 hours after randomization 72 hours after randomization	need for invasive mechanical ventilation	within 72 hours after randomization
Secondary	Rate of airleaks(pneumothorax and/or pneumomediastinum) occurred during noninvasive respiratory support	determined by the treating clinician by the treating clinician	during noninvasive respiratory support
Secondary	Rate of bronchopulmonary dysplasia	defined according to the NICHD definition	36 weeks of postmenstrual age
Secondary	Rate of retinopathy of prematurity (ROP)	= 2nd stage	Within 6 months after birth
Secondary	Rate of necrotizing enterocolitis (NEC)	= 2nd stage	through study completion, an average of 1 year
Secondary	Rate of intraventricular hemorrhage	= 3nd grade	through study completion, an average of 1 year