Monitoring Neonatal Resuscitation Trial

NCT03256578 | Completed Results DMC FDA Device

• 2 other identifiers: 826695NTR4104
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Resuscitation; Neonatal Prematurity; Positive-Pressure Respiration

Keywords

Resuscitation; Neonatal Prematurity; Positive-Pressure Ventilation; Respiratory Function Monitor

Outcome Measures

Primary Outcomes (1)

• Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg

  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 percentage of inflations performed with a predefined VTe "safe range" of 4 - 8 mls/kg.

  the first 15 minutes of resuscitation

Secondary Outcomes (25)

• Percentage of Oxygen Saturation (SpO2) in the First 5 Minutes of Life

  approximately first 5 minutes of life

• Heart Rate in the First 10 Minutes of Life

  between 3 and 10 minutes of life

• Percentage of Time With Mask Leak During PPV Ventilation

  approximately first 15 minutes of resuscitation

• Percentage of PPV Inflations With Airway Obstruction

  approximately first 15 minutes of resuscitation

• Percentage of PPV Inflations With Inadequate Tidal Volume

  approximately first 15 minutes of resuscitation

Study Arms (2)

RFM visible

EXPERIMENTAL

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.

Device: New Life Box Respiratory Function Monitor

RFM masked

NO INTERVENTION

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.

Interventions

New Life Box Respiratory Function Monitor 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 visible

Eligibility Criteria

• Age: 24 Weeks - 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Leiden University Medical Center: collaborator
• Royal Women's Hospital in Melbourne, Australia: collaborator
• Maternal & Children's University Hospital, Valencia, Spain: collaborator
• Vittore Buzzi Children's Hospital: collaborator
• Karolinska University Hospital: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (3)

• 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.

  PMID: 18192329 BACKGROUND

• 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.

  PMID: 19776023 BACKGROUND

• 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.

  PMID: 34302924 DERIVED

Results Point of Contact

• Title: Dr. Arjan te Pas
• Organization: Leiden University Medical Center

a.b.te_pas@lumc.nl

+31 71 5265839

Study Officials

• Arjan te Pas, MD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 22, 2017
• Study Start: February 20, 2017
• Primary Completion: May 17, 2019
• Study Completion: September 20, 2021
• Last Updated: November 22, 2021
• Results First Posted: January 19, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)