Clinical trial NCT02259400: NIV Strategies for RDS in Preterm Infants. NIV (Non Invasive Ventilation), RDS (Respiratory Distress Syndrome)
Official title: Noninvasive Ventilation Strategies for Early Treatment of RDS in Preterm Infants: An RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: RDS of Prematurity
Keywords: NIV
NSIPPV
BiPAP
Lead sponsor: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Sponsor class: OTHER
Collaborators: name: Vittore Buzzi Children's Hospital
name: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
First posted: 2014-10-08
Enrollment: 280
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether two different strategies of Non Invasive Ventilation (NIV) have different effect on length and failure of NIV support in preterm infants with respiratory distress syndrome (RDS).

Detailed description: A Randomized Control Trial (RCT) conducted in two tertiary level Neonatal Intensive Care Unit (NICU). Ethical approval is needed. Informed and written consent will be obtained prior the delivery from the parents of the babies before the inclusion in the study. All inborn Very Low Birth Weight (VLBW) infants (Birthweight less than 1500 g and Gestational Age \< 32 weeks) with signs of RDS, spontaneously breathing and only supported by nasal-Continuous Positive Airway Pressure (NCPAP) in NICU, will be randomized within the first 2 hours of life to receive two different Non Invasive Ventilation (NIV) strategies: Nasal Synchronized Intermittent Positive Pressure Ventilation (N-SIPPV) or Bilevel Continuous Positive Airway Pressure (BiPAP).

Eligibility criteria: Inclusion Criteria:

* All inborn VLBW infants (birthweight less than 1500 g and Gestational Age \< 32 wks) with signs of RDS, spontaneously breathing and only supported by N-CPAP, will be randomized within the first 2 hours of life to receive two different Non Invasive Ventilation (NIV) strategies.

Exclusion Criteria:

* Apneic or severely depressed newborns requiring invasive ventilation, within two hours from birth
* Newborns with genetic disease and/or with major congenital malformations
* Newborns for whom it was not obtained informed consent within two hours from birth

Primary outcomes:
measure: Duration of NIV Support
timeFrame: 10 days
measure: Failure of NIV Support
timeFrame: 10 days
Secondary outcomes:
measure: Death
timeFrame: 2 month
measure: Bronchopulmonary Dysplasia (BPD)
timeFrame: 36 weeks of postconceptional age or time of discharge
measure: Pneumothorax (PNX)
timeFrame: 10 days
measure: Intraventricular Hemorrhage (IVH)
timeFrame: 1 month of life
measure: Periventricular Leukomalacia (PVL)
timeFrame: 3 month of life
measure: Retinopathy of Prematurity (ROP)
timeFrame: 3 month of life
measure: Patent Ductus Arteriosus Requiring Pharmacological Treatment (PDA)
timeFrame: first week of life
measure: Necrotizing Enterocolitis (NEC)
timeFrame: 1 month
measure: Newborns Who Received Multiple Surfactant Doses
timeFrame: 10 days
measure: Early Onset Sepsis
timeFrame: 5days from birth
measure: Late Onset Sepsis
timeFrame: after fifth days of life up 2 month of life
measure: Death
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Azienda Ospedaliera Universitaria Policlinico "G Martino" Messina
name: Vincenzo V Salvo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Committee on Fetus and Newborn; American Academy of Pediatrics. Respiratory support in preterm infants at birth. Pediatrics. 2014 Jan;133(1):171-4. doi: 10.1542/peds.2013-3442. Epub 2013 Dec 30.
citation: Stevens TP, Harrington EW, Blennow M, Soll RF. Early surfactant administration with brief ventilation vs. selective surfactant and continued mechanical ventilation for preterm infants with or at risk for respiratory distress syndrome. Cochrane Database Syst Rev. 2007 Oct 17;2007(4):CD003063. doi: 10.1002/14651858.CD003063.pub3.
citation: Bhandari V. Nasal intermittent positive pressure ventilation in the newborn: review of literature and evidence-based guidelines. J Perinatol. 2010 Aug;30(8):505-12. doi: 10.1038/jp.2009.165. Epub 2009 Oct 22.
citation: Kirpalani H, Millar D, Lemyre B, Yoder BA, Chiu A, Roberts RS; NIPPV Study Group. A trial comparing noninvasive ventilation strategies in preterm infants. N Engl J Med. 2013 Aug 15;369(7):611-20. doi: 10.1056/NEJMoa1214533.
citation: Meneses J, Bhandari V, Alves JG, Herrmann D. Noninvasive ventilation for respiratory distress syndrome: a randomized controlled trial. Pediatrics. 2011 Feb;127(2):300-7. doi: 10.1542/peds.2010-0922. Epub 2011 Jan 24.
citation: Roberts CT, Davis PG, Owen LS. Neonatal non-invasive respiratory support: synchronised NIPPV, non-synchronised NIPPV or bi-level CPAP: what is the evidence in 2013? Neonatology. 2013;104(3):203-9. doi: 10.1159/000353448. Epub 2013 Aug 28.
citation: Ricotti A, Salvo V, Zimmermann LJ, Gavilanes AW, Barberi I, Lista G, Colivicchi M, Temporini F, Gazzolo D. N-SIPPV versus bi-level N-CPAP for early treatment of respiratory distress syndrome in preterm infants. J Matern Fetal Neonatal Med. 2013 Sep;26(13):1346-51. doi: 10.3109/14767058.2013.784255. Epub 2013 Apr 17.
citation: Salvo V, Lista G, Lupo E, Ricotti A, Zimmermann LJ, Gavilanes AW, Barberi I, Colivicchi M, Temporini F, Gazzolo D. Noninvasive ventilation strategies for early treatment of RDS in preterm infants: an RCT. Pediatrics. 2015 Mar;135(3):444-51. doi: 10.1542/peds.2014-0895. Epub 2015 Feb 9.