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Completed

NCT Number: NCT06740344

Neonatal Mask Seal; a Two-handed Versus One-handed Approach: The NeoSeal Study

When babies can't breathe effectively, we can use a facemask to give them breaths and oxygen. The mask can be held with one or two hands, depending on the preference of the doctor. Both types of mask holds are recommended in international guidelines, but it is unclear which one is better for the baby. If a lot of air is leaking around the mask, it means that the baby is not getting the full breathing support that the healthcare providers are trying to give. There currently is not enough evidence to say which type of hold is better to reduce this potential leaking of air.

In this study, the investigators will compare two different ways of holding a mask on a baby's face to help them breathe. Each baby will be randomly allocated to either a one-handed or a two-handed mask hold, and the investigators will measure how much air leaks out around the mask during each breath. Any baby in the neonatal unit may be included in this study.

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Key information

Conditions

Neonatal Intensive Care

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The National Maternity Hospital Dublin

Dublin, Leinster, D02 YH21, Ireland

About this study

This study will compare the measured leak in mask ventilation delivered by a healthcare professional in the neonatal team, using a one-handed versus a two-handed hold with a standardised mask size and shape. This is to assess the two-handed technique as a potential first-line approach in neonatal bag-mask ventilation.

The handholds will be assessed by a randomised controlled trial, with the two-handed hold as the intervention and the one-handed hold as the control.

The population that will be studied is neonates in the neonatal intensive care unit (NICU), at any gestation, who the clinical team have decided to intubate.

A member of the research team, who will provide an out-of-hours on call service, will attend the event. The relevant outcomes will be measured by the Monivent Neo100, which will be set up by the research team. Standardised masks, as used per local protocol, will be used, with the sensor module placed between that and the T-piece with an adaptor.

The outcomes will assess the effectiveness of both the intervention and control, including ventilation parameters recorded by the Monivent Neo100 and the clinical stability of the patient. The primary outcome of this study is the percentage mask leak.

A research team member will record data for primary and secondary outcome. The event will be filmed for post-hoc video analysis.

The outcome assessor will be blinded to the group allocation.

This research project will take place over 24 months, with an interim analysis to ensure recruitment is projected to achieve sample size.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All term and preterm neonates in the neonatal unit who the clinical team have decided to intubate, with or without pre-medication and who require mask ventilation prior to intubation attempt.

Exclusion criteria

  • Neonates with a congenital malformation that would impact mask seal will not be included.

Treatment and study plan

Two-handed facemask hold

Procedure

Two-handed mask hold technique while giving facemask ventilation, with another operator designated to deliver PIP via the T-piece.

Control: One-handed facemask hold

Procedure

One-handed mask hold technique while giving facemask ventilation, with the same operator holding the mask and delivering PPV via the T-piece.

Primary outcomes

  1. Mask leak

    Time frame: Over a maximum of 20 minutes

    Mask leak percentage, as measured by the Monivent Respiratory Function Monitor (RFM).

    Collected over a minimum of 5 breaths. Maximum of 2 episodes of facemask ventilation will be collected, with values averaged.

Secondary outcomes

  1. Lowest oxygen saturation

    Time frame: Over a maximum of 20 minutes

    Lowest oxygen saturation detected on the bedside clinical monitoring (Philips Intellivue MX800) during the period of facemask ventilation, recorded by a member of the research team.

  2. Highest supplemental FiO2 used during facemask ventilation

    Time frame: Over a maximum of 20 minutes

    Highest percentage FiO2 used during the period of facemask ventilation, as indicated by the set dial on the Neopuff.

  3. Positive inspiratory pressure during facemask ventilation

    Time frame: Over a maximum of 20 minutes

    Positive inspiratory pressure used during the period of facemask ventilation, as measured by the Monivent Neo100 respiratory function monitor.

  4. Percentage of obstructed breaths during facemask ventilation

    Time frame: Over a maximum of 20 minutes

    Percentage of obstructed breaths during the period of facemask ventilation, as measured by the Monivent Neo100 respiratory function monitor.

  5. Tidal volume during facemask ventilation

    Time frame: Over a maximum of 20 minutes

    Measured tidal volume during the period of facemask ventilation, as measured by the Monivent Neo100 respiratory function monitor.

  6. Number of times facemask position is adjusted during facemask ventilation

    Time frame: Over a maximum of 20 minutes

    Number of times clinical team needs to adjust mask position during the period of facemask ventilation.

  7. Duration of facemask ventilation

    Time frame: Over a maximum of 20 minutes

    Time duration of facemask ventilation

  8. Crossover to other handhold

    Time frame: Over a maximum of 20 minutes

    If allocated two-handed hold: Number of times clinical team elect to switch to one-handed hold.

    If allocated one-handed hold: Number of times clinical team elect to switch to two-handed hold.

  9. User opinion of mask hold

    Time frame: Over a maximum of 20 minutes

    Survey of operator opinions about mask hold used, and their usual preference.

  10. Lowest heart rate

    Time frame: Over a maximum of 20 minutes

    Lowest heart rate detected on the bedside clinical monitoring (Philips Intellivue MX800) during the period of facemask ventilation, recorded by a member of the research team.

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Registry information

Official study title

Neonatal Mask Seal; a Randomised Controlled Trial of Two-handed Versus One-handed Hold for Delivering Positive-pressure Ventilation With a Facemask in Preterm and Term Infants: The NeoSeal Study

Acronym: NeoSeal

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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