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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02772835
Date of registration:	03/05/2016
Prospective Registration:	No
Primary sponsor:	Fondazione Poliambulanza Istituto Ospedaliero
Public title:	nHFOV vs nCPAP: Effects on Gas Exchange for the Treatment of Neonates Recovering From RDS
Scientific title:	Nasal HFOV vs Nasal CPAP: Effects on Gas Exchange for the Treatment of Neonates Recovering From Respiratory Distress Syndrome. A Multicenter Randomized Controlled Trial
Date of first enrolment:	January 2016
Target sample size:	30
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02772835
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Italy	Lithuania

Contacts

Name:	Vladimiras Chijenas, Doctor
Address:
Telephone:
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Affiliation:	Vilnius University

Name:	Massimo Agosti, Doctor
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Affiliation:	Ospedale F. Del Ponte, Varese

Name:	Roberto Bottino, Doctor
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Affiliation:	Fondazione Poliambulanza Istituto Ospedaliero

Name:	Mariarosa Colnaghi, Doctor
Address:
Telephone:
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Affiliation:	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Name:	Gianluca Lista, Doctor
Address:
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Affiliation:	Vittore Buzzi Children's Hospital

Name:	Chiara Consigli, Doctor
Address:
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Affiliation:	Hospital San Pietro Fatebenefratelli

Name:	Arunas Liubsys, Doctor
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Affiliation:	Vilnius University

Name:	Giovanni Vento, Doctor
Address:
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Affiliation:	Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Name:	Gianfranco Maffei, Doctor
Address:
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Affiliation:	Ospedali Riuniti di Foggia

Key inclusion & exclusion criteria

Inclusion Criteria:

- Birthweight < 1500g and/or

- Gestational age < 32 weeks

- nCPAP treatment for > 24 h

- Oxygen supply to keep SaO2 87-94% for a minimum of 1 h prior to initiation of the
study

- Parents written informed consent

Exclusion Criteria:

- Active medical treatment for patent ductus arteriosus

- culture proven sepsis

- Major congenital malformations

- Genetic syndromes

- Postoperative recovery period of <24 h

Age minimum: N/A
Age maximum: 6 Months
Gender: All

Health Condition(s) or Problem(s) studied

Preterm Birth

Respiratory Distress Syndrome

Intervention(s)

Device: Medin-cno

Primary Outcome(s)

Comparison between nHFOV and nCPAP on gas exchange in premature infants with persistent oxygen need recovering from RDS, particularly on CO2 removal. [Time Frame: 4 hours]

Secondary Outcome(s)

Secondary ID(s)

NHVSNC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Vilnius University

Vittore Buzzi Children's Hospital

Ospedale F. Del Ponte, Varese

Hospital San Pietro Fatebenefratelli

Ospedali Riuniti di Foggia

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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