Comparison Of Respiratory Support After Delivery on Infants Born Before 28 Weeks Gestational Age

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2020-05-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Trial purpose: For infants born \<28 weeks of age, can initial respiratory resuscitation with new system (low imposed work of breathing and prongs) reduce the frequency of delivery room intubations compared to standard treatment with T-piece resuscitator system (high imposed work of breathing and face mask)?

Trial summary: This is a randomised controlled trial of delivery room intubation rates comparing a new system and T-piece resuscitation system for initial stabilisation of infants born \<28 weeks.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Different Oxygen Delivery Strategies During Resuscitation of Babies

NCT00356902

Prematurity Oxidative Injury Respiratory Distress

COMPLETED NA

Feasibility of Uninterrupted Infant Respiratory Support Treatment

NCT04244890

Respiratory Distress Syndrome, Newborn Infant, Newborn Respiratory Insufficiency Syndrome of Newborn

COMPLETED

Monitoring Neonatal Resuscitation Trial

NCT03256578

Resuscitation Neonatal Prematurity Positive-Pressure Respiration

COMPLETED NA

Non-inflatable Supraglottic Airway (NI-SGA) vs. Face Mask (FM) as a Primary Interface Device for Neonatal Resuscitation

NCT02629887

Neonatal Resuscitation

WITHDRAWN NA

Mask Ventilation With Different Face Masks During Neonatal Resuscitation

NCT01685697

Respiration; Insufficient or Poor, Newborn

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study is a two arm randomised comparison of two systems (T-piece device and the new system) for respiratory support after delivery of an infant born less than 28 weeks gestational age (GA). This multicentre trial will start at Karolinska University Hospital and other sites can join throughout the study period. The trial is academic with the coordinating investigator as sponsor. No company funding will be considered.

The new device has been designed for neonatal resuscitation and CE-marked for this intended use. The device is operated/handled in a similar way to existing devices and can provide support according to resuscitation guidelines.

During spontaneous breathing the continuous positive airway pressure (CPAP) provided with the new system is more pressure stable and has low imposed work of breathing. The benefits of decreased imposed work of breathing during resuscitation have not previously been investigated. The new system has the option of using prongs as the patient interface. Prongs have shown promising results in trials and have theoretical benefits. We hypothesis that the combined use of prongs and low imposed work of breathing could reduce the number of infants that need mechanical ventilation.

Screening for eligibility and consent will be performed on mothers with threatening delivery of an extremely premature infant (\<28 weeks gestational age). There is no lower gestational age limit but patients should not be included if there is a decision to intubate prior to delivery or treatment limitations.

After a patient has been enrolled the randomisation will be on hold until delivery is imminent. Randomisation will be stratified on centre, gestational age and antenatal steroid treatment. The interventions cannot be blinded.

The management of respiratory support is according to international guidelines and a detailed description is provided in the clinical management appendix. The intervention is respiratory support for the first 10-30 minutes of life and will begin after birth when the infant is transferred to the resuscitation team. The intervention ends 1) when an infant is intubated (primary outcome), 2) after a minimum of 10 minutes support, with the randomized system, the patient is stable and breathing adequately, 3) at 30 minutes when the respiratory support can continue as decided by the clinicians (cross-over not allowed).

Apart from the system used for respiratory support all patients will receive standard care. No assessments or investigations of the trial subjects are planned. Data will be reported by the resuscitation team and collected from records.

The primary outcome is delivery room intubation or death. The secondary outcomes include time to intubation, use of surfactant, use of positive pressure ventilation, respiratory support at 72 hours and temperature on intensive care admission. Safety variables include pneumothorax, intraventricular haemorrhage and problems with ventilation and equipment.

All analysis will be on intention to treat and p\<0.05 considered statistically significant. The primary outcome variable (delivery room intubation or death) will represent a 2x2 cross table and analysed with Pearson chi-square test. The secondary outcomes include Kaplan Meier analysis of time to intubation and comparisons of means for continuous variables. There are no predetermined subgroups. Subgroup analysis will be used to describe the population and to generate hypotheses.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiration; Insufficient or Poor, Newborn Infant, Premature, Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Reference Device: T-piece System

Group Type ACTIVE_COMPARATOR

T-piece used for respiratory support (several manufacturers)

Intervention Type DEVICE

Infants will receive support by a standard T-piece resuscitator system (manufacturer not dictated in protocol). Apart from the system used for respiratory support all patients will receive standard care (specified in management protocol)

Investigational Device: The New System

Group Type ACTIVE_COMPARATOR

New system used for respiratory support

Intervention Type DEVICE

Infants will receive support by the new system (manufactured by Inspiration Healthcare, UK). Apart from the system used for respiratory support all patients will receive standard care (specified in management protocol)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

T-piece used for respiratory support (several manufacturers)

Infants will receive support by a standard T-piece resuscitator system (manufacturer not dictated in protocol). Apart from the system used for respiratory support all patients will receive standard care (specified in management protocol)

Intervention Type DEVICE

New system used for respiratory support

Infants will receive support by the new system (manufactured by Inspiration Healthcare, UK). Apart from the system used for respiratory support all patients will receive standard care (specified in management protocol)

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Neopuff™ Infant T-Piece Resuscitator T-piece Disposable Circuit Kit (GE Healthcare) Other T-piece manufacturers Manufacturing and CE-marking by Inspiration Healthcare, UK

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Born \<28 weeks gestational age at a university hospital
2. Delivery can be vaginal or with caesarean section and steroid prophylaxis to mother can be complete, incomplete or not given

Exclusion Criteria

1. Decision on treatment limitations before randomisation
2. Decision to intubate infant made before delivery (for example local routine for infants born before 23 weeks GA)
3. Known airway, pulmonary, cardiac, gastro-intestinal tract malformations
4. Known neuromuscular disease
5. No study neonatologist available

Eligible Sex

ALL

Accepts Healthy Volunteers

No