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Monitoring Neonatal Resuscitation Trial

NCT ID: NCT03256578

Last Updated: 2021-11-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-20

Study Completion Date

2021-09-20

Brief Summary

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This is a randomized trial to determine if a visible respiratory function monitor (RFM) displaying realtime measurements of delivered inflations improves clinical providers ability to perform positive pressure ventilation (PPV) within a pre-defined target tidal volume in preterm infants after birth.

Detailed Description

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Recently, it has been demonstrated that the use of a respiratory function monitor (RFM) can guide PPV in the DR.(Wood, Schmolzer) In this study, the New Life Box, (Advanced Life Diagnostics, Weener, Germany) a neonatal Respiratory Monitor (RFM), will be used to measure and calculate inflation pressures, flow, and tidal volumes in all enrolled infants. The New Life Box uses a small variable orifice anemometer to measure gas flow in and out of a face-mask or endotracheal tube. This signal is automatically integrated to provide inspired (Vti) and expired (Vte) tidal volume. The difference equals the leak from the facemask or endotracheal tube. Complete airway obstruction occurs when no flow of gas into or away from the infant is seen during a positive pressure inflation. The RFM can also calculate and measure respiratory rate and minute volume, inflations and spontaneous inspirations, and all ventilation pressures. Using customized software heart rate, oxygen saturation and expired carbon dioxide can be integrated into the RFM.

The NewLife Box monitor presents graphical information for pressure, flow, and volume. In addition, the monitor displays numeric data for pressure (PIP and PEEP), tidal volume (Vti, Vte), flow, respiratory rate and percent leak. The monitor integrates and displays physiologic data streaming from the patient (heart rate and oxygen saturation) as well as FiO2 from an oxygen analyzer in the inspiratory limb of the respiratory circuit. If enabled, the monitor can incorporate video captured from an external camera. The video serves as a helpful aid in the interpretation of the events during the RFM waveform recordings.

The use of an RFM in the DR has the potential to improve neonatal respiratory support and reduce lung injury.

The primary objective of this study is to test the hypothesis that observing the data and waveforms displayed on an RFM during the provision of PPV to preterm infants (24-27 6/7 weeks gestation) after birth will increase the proportion of inflations performed with a predefined VTe "safe range" of 4 - 8 mls/kg.

Conditions

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Resuscitation Neonatal Prematurity Positive-Pressure Respiration

Keywords

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Resuscitation Neonatal Prematurity Positive-Pressure Ventilation Respiratory Function Monitor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Eligible infants are either randomized to the intervention, where the clinical team will be able to directly observe the monitor or randomized to the RFM-masked display arm, where they will only see a black screen.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
The waveform data and videos captured during the study intervention will be centralized to Leiden University Medical Center. The team at Leiden University Medical Center assessing the outcomes will be will be blinded to the randomization allocation of the infant.

Study Groups

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RFM visible

During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen.

Group Type EXPERIMENTAL

New Life Box Respiratory Function Monitor

Intervention Type DEVICE

The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.

RFM masked

During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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New Life Box Respiratory Function Monitor

The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Gestational age (GA) 24 - 27 6/7 weeks at birth, by best obstetrical
* Receive positive pressure ventilation during delivery room resuscitation

Exclusion Criteria

* Known major anomalies including that may affect measured cardiorespiratory parameters: congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease, pulmonary hypoplasia
* RFM not available during resuscitation
Minimum Eligible Age

24 Weeks

Maximum Eligible Age

28 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leiden University Medical Center

OTHER

Sponsor Role collaborator

Royal Women's Hospital in Melbourne, Australia

UNKNOWN

Sponsor Role collaborator

Maternal & Children's University Hospital, Valencia, Spain

OTHER

Sponsor Role collaborator

Vittore Buzzi Children's Hospital

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Foglia

Assistant Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arjan te Pas, MD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Wood FE, Morley CJ, Dawson JA, Davis PG. A respiratory function monitor improves mask ventilation. Arch Dis Child Fetal Neonatal Ed. 2008 Sep;93(5):F380-1. doi: 10.1136/adc.2007.120097. Epub 2008 Jan 11.

Reference Type BACKGROUND
PMID: 18192329 (View on PubMed)

Schmolzer GM, Kamlin OC, Dawson JA, te Pas AB, Morley CJ, Davis PG. Respiratory monitoring of neonatal resuscitation. Arch Dis Child Fetal Neonatal Ed. 2010 Jul;95(4):F295-303. doi: 10.1136/adc.2009.165878. Epub 2009 Sep 22.

Reference Type BACKGROUND
PMID: 19776023 (View on PubMed)

van Zanten HA, Kuypers KLAM, van Zwet EW, van Vonderen JJ, Kamlin COF, Springer L, Lista G, Cavigioli F, Vento M, Nunez-Ramiro A, Oberthuer A, Kribs A, Kuester H, Horn S, Weinberg DD, Foglia EE, Morley CJ, Davis PG, Te Pas AB. A multi-centre randomised controlled trial of respiratory function monitoring during stabilisation of very preterm infants at birth. Resuscitation. 2021 Oct;167:317-325. doi: 10.1016/j.resuscitation.2021.07.012. Epub 2021 Jul 22.

Reference Type DERIVED
PMID: 34302924 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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NTR4104

Identifier Type: REGISTRY

Identifier Source: secondary_id

826695

Identifier Type: -

Identifier Source: org_study_id