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

RDS of Prematurity Clinical Trial

— NIV  

Official title:

Noninvasive Ventilation Strategies for Early Treatment of RDS in Preterm Infants: An RCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02259400
• Other study ID #: NIV/RDS-01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 2, 2014
• Last updated: January 30, 2015
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: January 2015
• Source: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Hours

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• RDS of Prematurity
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

Device:
• NSIPPV
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.
• BiPAP
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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Policlinico "G. Martino"	Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo, Vittore Buzzi Children's Hospital

References & Publications (7)

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. Review. Erratum in: J Perinatol. 2010 Dec;30(12):827. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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;(4):CD003063. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of NIV Support	DURATION OF NON INVASIVE VENTILATION SUPPORT FOR RDS TREATMENT	10 days	No
Primary	Failure of NIV Support	NUMBER OF NEWBORNS WHO FAILED WITH NON INVASIVE VENTILATION SUPPORT AND NEEDED INTUBATION AND INVASIVE MECHANICAL VENTILATION.	10 days	No
Secondary	Death		2 month	No
Secondary	Bronchopulmonary Dysplasia (BPD)		36 weeks of postconceptional age or time of discharge	No
Secondary	Pneumothorax (PNX)		10 days	Yes
Secondary	Intraventricular Hemorrhage (IVH)		1 month of life	No
Secondary	Periventricular Leukomalacia (PVL)		3 month of life	No
Secondary	Retinopathy of Prematurity (ROP)		3 month of life	No
Secondary	Patent Ductus Arteriosus Requiring Pharmacological Treatment (PDA)		first week of life	No
Secondary	Necrotizing Enterocolitis (NEC)		1 month	No
Secondary	Newborns Who Received Multiple Surfactant Doses		10 days	No
Secondary	Early Onset Sepsis		5days from birth	No
Secondary	Late Onset Sepsis		after fifth days of life up 2 month of life	No
Secondary	Death		1 month	No