NIV Strategies for RDS in Preterm Infants. NIV (Non Invasive Ventilation), RDS (Respiratory Distress Syndrome)

NCT02259400 | Completed Phase 2 Results

• 1 other identifier: NIV/RDS-01
• Study Type: interventional
• Target: 280
• Locations: 0 countries
• Sites: N/A

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).

Conditions

RDS of Prematurity

Keywords

NIV; NSIPPV; BiPAP

Outcome Measures

Primary Outcomes (2)

• Duration of NIV Support

  DURATION OF NON INVASIVE VENTILATION SUPPORT FOR RDS TREATMENT

  10 days

• Failure of NIV Support

  NUMBER OF NEWBORNS WHO FAILED WITH NON INVASIVE VENTILATION SUPPORT AND NEEDED INTUBATION AND INVASIVE MECHANICAL VENTILATION.

  10 days

Secondary Outcomes (12)

• Death

  2 month

• Bronchopulmonary Dysplasia (BPD)

  36 weeks of postconceptional age or time of discharge

• Pneumothorax (PNX)

  10 days

• Intraventricular Hemorrhage (IVH)

  1 month of life

• Periventricular Leukomalacia (PVL)

  3 month of life

Study Arms (2)

NSIPPV group

ACTIVE COMPARATOR

The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter for LBW infants), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants'weight, will be used as interface.

Device: NSIPPV

BiPAP group

ACTIVE COMPARATOR

The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants' weight.

Device: BiPAP

Interventions

NSIPPV DEVICE

In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)\< 0.3.

NSIPPV group

BiPAP DEVICE

In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 \< 0.3.

BiPAP group

Eligibility Criteria

• Age: Up to 2 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico "G. Martino": lead
• Vittore Buzzi Children's Hospital: collaborator
• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: collaborator

Related Publications (8)

• 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.

  PMID: 24379228 BACKGROUND

• 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.

  PMID: 17943779 BACKGROUND

• 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.

  PMID: 19847188 BACKGROUND

• 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.

  PMID: 23944299 BACKGROUND

• 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.

  PMID: 21262883 BACKGROUND

• 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.

  PMID: 23989138 BACKGROUND

• 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.

  PMID: 23488612 BACKGROUND

• 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.

  PMID: 25667244 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome In Premature Infants

Results Point of Contact

• Title: Dr. Vincenzo Salvo
• Organization: AOU "G. Martino" Universitary Hospital of Messina

salvovincenzo@virgilio.it

+39 0902212132

Study Officials

• Vincenzo V Salvo, MD

  Azienda Ospedaliera Universitaria Policlinico "G Martino" Messina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Neonatal Intensive Care Unit, Pediatric Department

Study Record Dates

• First Submitted: October 2, 2014
• First Posted: October 8, 2014
• Study Start: January 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 18, 2015
• Results First Posted: January 28, 2015

Record last verified: 2015-01