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

January 30, 2015 updated by: Vincenzo Salvo, MD, Azienda Ospedaliera Universitaria Policlinico "G. Martino"

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 hours (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: NSIPPV group
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
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.
ACTIVE_COMPARATOR: BiPAP group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of NIV Support
Time Frame: 10 days
DURATION OF NON INVASIVE VENTILATION SUPPORT FOR RDS TREATMENT
10 days
Failure of NIV Support
Time Frame: 10 days
NUMBER OF NEWBORNS WHO FAILED WITH NON INVASIVE VENTILATION SUPPORT AND NEEDED INTUBATION AND INVASIVE MECHANICAL VENTILATION.
10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: 1 month
1 month
Death
Time Frame: 2 month
2 month
Bronchopulmonary Dysplasia (BPD)
Time Frame: 36 weeks of postconceptional age or time of discharge
36 weeks of postconceptional age or time of discharge
Pneumothorax (PNX)
Time Frame: 10 days
10 days
Intraventricular Hemorrhage (IVH)
Time Frame: 1 month of life
1 month of life
Periventricular Leukomalacia (PVL)
Time Frame: 3 month of life
3 month of life
Retinopathy of Prematurity (ROP)
Time Frame: 3 month of life
3 month of life
Patent Ductus Arteriosus Requiring Pharmacological Treatment (PDA)
Time Frame: first week of life
first week of life
Necrotizing Enterocolitis (NEC)
Time Frame: 1 month
1 month
Newborns Who Received Multiple Surfactant Doses
Time Frame: 10 days
10 days
Early Onset Sepsis
Time Frame: 5days from birth
5days from birth
Late Onset Sepsis
Time Frame: after fifth days of life up 2 month of life
after fifth days of life up 2 month of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Collaborators

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Vittore Buzzi Children's Hospital

Investigators

  • Principal Investigator: Vincenzo V Salvo, MD, Azienda Ospedaliera Universitaria Policlinico "G Martino" Messina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

October 2, 2014

First Submitted That Met QC Criteria

October 4, 2014

First Posted (ESTIMATE)

October 8, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 18, 2015

Last Update Submitted That Met QC Criteria

January 30, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIV/RDS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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