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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02259400
Acronym
NIV
Enrollment
280
Registered
2014-10-08
Start date
2010-01-31
Completion date
2012-12-31
Last updated
2015-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RDS of Prematurity

Keywords

NIV, NSIPPV, BiPAP

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).

Interventions

DEVICENSIPPV

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.

DEVICEBiPAP

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.

Sponsors

Vittore Buzzi Children's Hospital
CollaboratorOTHER
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
CollaboratorOTHER
Azienda Ospedaliera Universitaria Policlinico G. Martino
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 2 Hours
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Duration of NIV Support10 daysDURATION OF NON INVASIVE VENTILATION SUPPORT FOR RDS TREATMENT
Failure of NIV Support10 daysNUMBER OF NEWBORNS WHO FAILED WITH NON INVASIVE VENTILATION SUPPORT AND NEEDED INTUBATION AND INVASIVE MECHANICAL VENTILATION.

Secondary

MeasureTime frame
Death2 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
Retinopathy of Prematurity (ROP)3 month of life
Patent Ductus Arteriosus Requiring Pharmacological Treatment (PDA)first week of life
Necrotizing Enterocolitis (NEC)1 month
Newborns Who Received Multiple Surfactant Doses10 days
Early Onset Sepsis5days from birth
Late Onset Sepsisafter fifth days of life up 2 month of life

Participant flow

Recruitment details

We enrolled 280 VLBW infants with RDS, delivered before 32 weeks of gestational age and with a birth weight \<1500 gr, admitted in two NICUs (C. Arrigo, Children's Hospital, Alessandria, Italy and V. Buzzi, Children's Hospital, Milan, Italy) from January 2010 to December 2012.

Pre-assignment details

156 Newborns were excluded from the study: 19 had exclusion criteria, 40 not requiring ventilation support, 35 requiring invasive ventilation, 62 not randomized within 2 hours from birth. 124 newborns needed NIV within 2-h from birth, were randomly allocated to receive either NSIPPV (n=62) or BiPAP (n=62).

Participants by arm

ArmCount
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), 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. 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.
62
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. 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.
62
Total124

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath02

Baseline characteristics

CharacteristicNSIPPV GroupBiPAP GroupTotal
Age, Continuous28.6 WEEKS
STANDARD_DEVIATION 2.1
28.8 WEEKS
STANDARD_DEVIATION 2.2
28.7 WEEKS
STANDARD_DEVIATION 2.3
Age, Customized
> 26 and ≤29 wGA
33 participants32 participants65 participants
Age, Customized
≤ 26 wGA
9 participants9 participants18 participants
Age, Customized
> 29 wGA
20 participants21 participants41 participants
BIRTH-WEIGHT1106 GRAMS
STANDARD_DEVIATION 276
1165 GRAMS
STANDARD_DEVIATION 275
1135 GRAMS
STANDARD_DEVIATION 289
Sex: Female, Male
Female
35 Participants37 Participants72 Participants
Sex: Female, Male
Male
27 Participants25 Participants52 Participants
SMALL FOR GESTATIONAL AGE14 participants12 participants26 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 620 / 62
serious
Total, serious adverse events
2 / 626 / 62

Outcome results

Primary

Duration of NIV Support

DURATION OF NON INVASIVE VENTILATION SUPPORT FOR RDS TREATMENT

Time frame: 10 days

ArmMeasureValue (MEDIAN)
NSIPPV GroupDuration of NIV Support89 HOURS
BiPAP GroupDuration of NIV Support87 HOURS
p-value: <0.05Wilcoxon (Mann-Whitney)
Primary

Failure of NIV Support

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

Time frame: 10 days

ArmMeasureValue (NUMBER)
NSIPPV GroupFailure of NIV Support10 participants
BiPAP GroupFailure of NIV Support8 participants
Secondary

Bronchopulmonary Dysplasia (BPD)

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

Population: 2 newborns died in bipap group

ArmMeasureValue (NUMBER)
NSIPPV GroupBronchopulmonary Dysplasia (BPD)7 participants
BiPAP GroupBronchopulmonary Dysplasia (BPD)7 participants
Secondary

Death

Time frame: 1 month

ArmMeasureValue (NUMBER)
NSIPPV GroupDeath0 participants
BiPAP GroupDeath2 participants
Secondary

Death

Time frame: 2 month

ArmMeasureValue (NUMBER)
NSIPPV GroupDeath0 participants
BiPAP GroupDeath2 participants
Secondary

Early Onset Sepsis

Time frame: 5days from birth

ArmMeasureValue (NUMBER)
NSIPPV GroupEarly Onset Sepsis13 participants
BiPAP GroupEarly Onset Sepsis15 participants
Secondary

Intraventricular Hemorrhage (IVH)

Time frame: 1 month of life

ArmMeasureValue (NUMBER)
NSIPPV GroupIntraventricular Hemorrhage (IVH)2 participants
BiPAP GroupIntraventricular Hemorrhage (IVH)2 participants
Secondary

Late Onset Sepsis

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

ArmMeasureValue (NUMBER)
NSIPPV GroupLate Onset Sepsis21 participants
BiPAP GroupLate Onset Sepsis14 participants
Secondary

Necrotizing Enterocolitis (NEC)

Time frame: 1 month

ArmMeasureValue (NUMBER)
NSIPPV GroupNecrotizing Enterocolitis (NEC)0 participants
BiPAP GroupNecrotizing Enterocolitis (NEC)2 participants
Secondary

Newborns Who Received Multiple Surfactant Doses

Time frame: 10 days

ArmMeasureValue (NUMBER)
NSIPPV GroupNewborns Who Received Multiple Surfactant Doses21 participants
BiPAP GroupNewborns Who Received Multiple Surfactant Doses18 participants
Secondary

Patent Ductus Arteriosus Requiring Pharmacological Treatment (PDA)

Time frame: first week of life

ArmMeasureValue (NUMBER)
NSIPPV GroupPatent Ductus Arteriosus Requiring Pharmacological Treatment (PDA)18 participants
BiPAP GroupPatent Ductus Arteriosus Requiring Pharmacological Treatment (PDA)14 participants
Secondary

Periventricular Leukomalacia (PVL)

Time frame: 3 month of life

ArmMeasureValue (NUMBER)
NSIPPV GroupPeriventricular Leukomalacia (PVL)2 participants
BiPAP GroupPeriventricular Leukomalacia (PVL)4 participants
Secondary

Pneumothorax (PNX)

Time frame: 10 days

ArmMeasureValue (NUMBER)
NSIPPV GroupPneumothorax (PNX)2 participants
BiPAP GroupPneumothorax (PNX)4 participants
Secondary

Retinopathy of Prematurity (ROP)

Time frame: 3 month of life

ArmMeasureValue (NUMBER)
NSIPPV GroupRetinopathy of Prematurity (ROP)2 participants
BiPAP GroupRetinopathy of Prematurity (ROP)3 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026