Randomized Control Trial: Synchronized Non-invasive Positive Pressure Ventilation Versus Non Synchronized Non Invasive Positive Pressure Ventilation in Extremely Low Birth Weight Infants

NCT03613987 | Completed DMC FDA Device

• 1 other identifier: L12,175
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Infants delivered weighing less than 1 kg at birth (ELBW) are at high risk for the development of bronchopulmonary dysplasia (BPD) and Ventilator-Induced Lung Injury (VILI), in part because of the need for mechanical ventilation utilizing an endotracheal tube (MVET). In spite of strategies to minimize the need for MVET, the incidence of BPD in ELBW infants continues to be 20-80%. The hypothesis is that synchronized NIPPV will decrease the need for MVET and reduce BPD in ELBW infants as compared to NIPPV.

Conditions

BPD - Bronchopulmonary Dysplasia

Outcome Measures

Primary Outcomes (2)

• The need for Mechanical Ventilation via ET tube ( MVET) at 7 days of life

  Mechanical ventilation via Endotracheal tube

  7 days of life

• The need for Mechanical Ventilation via ET tube ( MVET) at 28 days of life

  Mechanical Ventilation via Endotracheal tube

  28 days of life

Secondary Outcomes (1)

• Incidence of BPD or need for supplemental O2 at 36 weeks corrected age

  36 weeks corrected gestational age

Study Arms (2)

NIPPV

NO INTERVENTION

non synchronized non invasive positive pressure ventilation

NAVA-NIPPV

EXPERIMENTAL

synchronized non invasive positive pressure ventilation with NAVA

Device: NAVA technology to synchronize NIPPV

Interventions

NAVA technology to synchronize NIPPV DEVICE

Neurally adjust ventilator assist is used to synchronize the NIPPV

NAVA-NIPPV

Eligibility Criteria

• Age: 24 Weeks - 30 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Babies born less than 1kg.
• Babies born at 24-30 weeks gestation.
• Babies who qualify for surfactant administration within 90mins of birth:
• FiO2 \> 0.4,
• nCPAP \> 6, with
• Increased work of breathing as noted by grunting; and/or inter-, sub-, or supra-sternal retractions.

You may not qualify if:

• Babies with Grade 3-4 IVH (may not be known prior to randomization).
• Babies with congenital anomalies including neuromuscular disorder.
• Babies who do not require intubation until 7 days of life.

Sponsors & Collaborators

• New York Medical College: lead

Study Sites (1)

Westchester Medical Center

Valhalla, New York, 10595, United States

Location

Related Publications (1)

• Louie K, Amatya S, Alpan G, Parton LA. Non-Invasive Ventilation with Neurally Adjusted Ventilatory Assist (NAVA) Improves Extubation Outcomes in Extremely Low-Birth-Weight Infants. Children (Basel). 2024 Sep 28;11(10):1184. doi: 10.3390/children11101184.

  PMID: 39457149 DERIVED

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Lance Parton, MD

  Westchester Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 3, 2018
• Study Start: April 26, 2018
• Primary Completion: July 26, 2022
• Study Completion: July 26, 2022
• Last Updated: March 27, 2023

Record last verified: 2023-03

Locations

US (1)