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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

780 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2029-01-01

Brief Summary

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Many extremely premature infants, born before 28 weeks' gestation age, 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.

Detailed Description

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Conditions

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Neonatal Resuscitation Apnea Neonatal

Keywords

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Premature Infant Preterm Neonates Oxygen Lung Injury Respiration, Artificial Resuscitation Ventilator, Mechanical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study will be a cluster-crossover, unmasked randomized control trial (RCT) comparing the clinical effectiveness of two existing methods for providing PPV to preterm neonates born 25+0 to 28+6 weeks gestational age during initial resuscitation after birth.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The DSMB will assess intervention compliance and mortality rates, masked to the group allocation. The trial statistician will be blinded to group allocations.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

T-piece resuscitator (TPR)

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Ventilator derived positive pressure ventilation - V-PPV

Intervention Type 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.

Interventions

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Ventilator derived positive pressure ventilation - V-PPV

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.

Intervention Type DEVICE

T-piece resuscitator (TPR)

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* GA 25+0 to 28+6 weeks using the best available obstetrical estimate
* Designated to receive full resuscitation, i.e., not pre-determined to receive only comfort care
* Received PPV as determined by the resuscitation team during the first 10 minutes of birth

Exclusion Criteria

* Outborn birth status
* Resuscitation performed in unforeseen circumstances outside typical delivery room (e.g., emergency department, antenatal ward)
* Known major congenital or chromosomal anomaly
* Established spontaneous respiration without receipt of PPV

Minimum Eligible Age

25 Weeks

Maximum Eligible Age

29 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Michelle Baczynski

Respiratory Therapist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michelle Baczynski, MSc

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

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