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Completed

NCT Number: NCT02259400

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

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).

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Key information

Conditions

RDS of Prematurity Respiratory Distress Syndrome In Premature Infants

Age range

Up to 2 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Duration of NIV Support

    Time frame: 10 days

    DURATION OF NON INVASIVE VENTILATION SUPPORT FOR RDS TREATMENT

  2. 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.

Secondary outcomes

  1. Death

    Time frame: 2 month

  2. Bronchopulmonary Dysplasia (BPD)

    Time frame: 36 weeks of postconceptional age or time of discharge

  3. Pneumothorax (PNX)

    Time frame: 10 days

  4. Intraventricular Hemorrhage (IVH)

    Time frame: 1 month of life

  5. Periventricular Leukomalacia (PVL)

    Time frame: 3 month of life

  6. Retinopathy of Prematurity (ROP)

    Time frame: 3 month of life

  7. Patent Ductus Arteriosus Requiring Pharmacological Treatment (PDA)

    Time frame: first week of life

  8. Necrotizing Enterocolitis (NEC)

    Time frame: 1 month

  9. Newborns Who Received Multiple Surfactant Doses

    Time frame: 10 days

  10. Early Onset Sepsis

    Time frame: 5days from birth

  11. Late Onset Sepsis

    Time frame: after fifth days of life up 2 month of life

  12. Death

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Policlinico "G. Martino"

Other

Collaborators

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

Registry information

Official study title

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

Acronym: NIV

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 8, 2014
Registry last updated
Feb 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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