Manual T-piece Versus Ventilator Positive Pressure Ventilation During Resuscitation of Extremely Premature Neonates

Part of paid clinical trials in Los Angeles, California.

Sponsor
Michelle Baczynski
Study ID
NCT06849596
Status
Recruiting
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Conditions

  • Apnea Neonatal
  • Neonatal Resuscitation

Eligibility Criteria

Sex
ALL
Age
25 Weeks - 29 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Ventilator derived positive pressure ventilation - V-PPV — DEVICE
    The clinical team will determine the need for PPV, as per local practice and Neonatal Resuscitation Program. Each site will be previously randomized to their method of providing PPV for preterm neonates during the first 10 minutes after birth. Ventilator delivered positive pressure ventilation (V-PPV) using a nasal interface will be delivered to the infant in the resuscitation room.
  • T-piece resuscitator (TPR) — DEVICE
    The clinical team will determine the need for PPV, as per local practice and Neonatal Resuscitation Program. Each site will be previously randomized to their method of providing PPV for preterm neonates during the first 10 minutes after birth. PPV will be provided with a T-piece resuscitator (Neopuff, Fisher \& Paykel Healthcare) connected to an appropriately sized face-mask.

Study Details

Many extremely premature infants require immediate help with breathing after birth. Positive pressure ventilation (PPV) using a device called a T-piece resuscitator is a common method. PPV is needed to establish proper lung function, improve gas exchange, and encourage the infant to breathe spontaneously. However, T-piece resuscitators have limitations, like a lack of visual feedback and variable settings, which may result in reduced effectiveness of PPV. Improving PPV effectiveness may reduce the need for more invasive procedures, such as intubation, which pose an increased risk of complications and death for these fragile infants. A novel approach, that may overcome the above limitations and deliver PPV with precise settings through a nasal mask, is to use a ventilator to deliver PPV (V-PPV) using a respiratory mode called nasal intermittent positive pressure ventilation (NIPPV). While NIPPV is commonly used in neonatal intensive care units to support breathing in premature infants, the impact of V-PPV use during immediate post-birth stabilization needs to be studied. Preliminary data from our recent single-center study confirmed the feasibility of using V-PPV for resuscitation of extremely premature babies and indicated its potential superiority with a 28% decrease in the need for intubation compared to historical use of T-piece. This promising innovation may enhance outcomes for these vulnerable infants by refining the way we provide respiratory support in their critical first moments. The research objective is to compare the clinical outcomes of extremely premature infants receiving manual T-piece versus V-PPV during immediate post-birth stabilization. The primary aim is to evaluate the impact of V-PPV on major health complications or death. This study seeks to provide insights into improving the care and outcomes of these infants during a critical stage of transition from fetus to newborn.

Key Dates

Start date
Dec 1, 2025
Status verified
Jun 2026
Primary completion
Sep 30, 2028
Completion
Jan 1, 2029

Study Design

Enrollment
780 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control group (T-Piece Resuscitator)
    Positive pressure ventilation during the first 10 minutes after birth will be provided with a T-Piece Resuscitator (TPR; Neopuff, Fisher \& Paykel Healthcare) connected to an appropriately sized face-mask, with settings adjustable within specified ranges for positive inspiratory pressure, positive end expiratory pressure, and fraction of inspired oxygen based on local policy. These specified ranges will be standardized across sites.
  • Experimental: Intervention under investigation (Ventilator delivered PPV)
    Positive pressure ventilation (PPV) during the first 10 minutes after birth will be provided using a neonatal ventilator set up in noninvasive positive pressure ventilation (NIPPV) mode, connected to an appropriately sized nasal mask or prongs and a dual limb neonatal ventilator circuit, with settings adjustable within specified ranges for positive inspiratory pressure, positive end expiratory pressure, respiratory rate and inspiratory time and fraction of inspired oxygen based on local policy. These specified ranges will be standardized across sites.

Primary Outcome Measure

Composite of pre-discharge mortality [ Time Frame: From enrollment through study completion (up to 50 weeks postmenstrual age) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Guerin Children'sLos AngelesCalifornia90505
Manoj Biniwale, MD
[email protected]
310-423-4434
Manoj Biniwale, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Guerin Children's· Los Angeles, CA

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