RecruitingACTRN12614000245695

A pilot study on delivery suite mask ventilation in extremely preterm infants

A pilot study comparing the respiratory function parameters of 1-person and 2-person mask technique in delivery suite for extremely preterm infants on reducing mask leak


Sponsor

Neonatal Intensive Care Unit, Westmead Hospital

Enrollment

40 participants

Start Date

Nov 1, 2014

Study Type

Interventional

Conditions

Summary

Neonatal mask ventilation (artificial breathing) is a technique that requires mastering, and previous simulation studies on manikin model suggest that mask leak is very common and significant in magnitude. Also airways obstruction occurs frequently when a resuscitator tries to minimise leak. A few studies in extremely preterm infants have suggested airways obstruction is common immediately after birth in infants requiring positive pressure ventilation. Studies in manikin models have described a simple 2-person four hand technique of mask ventilation that halves mask leak. Current UK neonatal guidelines (2010)suggest to consider using 2-person airway control on the basis of manikin studies. We propose to compare the current 1 person mask technique (Australian Resuscitation Council guideline, 2010) to 2 person mask technique. There are no studies available to inform which method is better. Aims : To measure respiratory function (lung function) parameters (mask leak, tidal volume, minute ventilation, end tidal CO2), and cerebral blood flow while using 1-person vs 2-person mask technique in delivery suite for extremely preterm infants.


Eligibility

Sex: Both males and femalesMin Age: 0 HourssMax Age: 0 Hourss

Plain Language Summary

Simplified for easier understanding

This study is comparing two techniques for giving assisted breathing to extremely premature babies in the delivery room: one person holding the mask versus two people holding the mask together. Premature babies often need help breathing right after birth, and researchers want to find out which technique causes less air leaking around the mask and delivers breathing support more effectively. You may be eligible if: - Your baby is born before 30 weeks of pregnancy - Your baby needs breathing support in the delivery room You may NOT be eligible if: - Your baby has a serious birth defect that affects survival - Your baby has an upper airway abnormality - The research team is not available at the time of birth Talk to your doctor about whether this trial might be right for you.

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Interventions

In 1-person method (which is the current standard technique) the resuscitator holds the mask in place with one hand and uses the other hand to provide positive pressure ventilation. In the 2-person me

In 1-person method (which is the current standard technique) the resuscitator holds the mask in place with one hand and uses the other hand to provide positive pressure ventilation. In the 2-person method, one person holds the mask in place and the other person provides the positive pressure ventilation. Positive Pressure Ventilation(PPV) will be supplied if needed clinically as per International Liaison Commission on Resuscitation (ILCOR) guidelines using either a t-piece resuscitator (Neopuff (TM), Fisher & Paykel Healthcare, Auckland New Zealand) with starting settings of FiO2 30% Pressures of 25 cm H2O for peak inflation pressure and 5 cm H2O for positive end expiratory pressure. Self-inflating bag (Laerdal Medical, New York, USA) is also used routinely, as an alternative. Current routine care for premature infants born < 30wks gestation at Westmead includes the use of an intensive care newborn transport system that includes a neonatal ventilator, respiratory mechanics monitor and tissue saturation monitoring. A respiratory function monitor (Respironics NM3, Philips Healthcare, Best, The Netherlands) will be used in line with the mask to measure respiratory function parameters. This includes a sensitive end tidal CO2 monitor needed for clinical certainty for Endo Tracheal Tube (ETT) placement. A NIRS (Near Infra-Red Spectroscopy, Nonin Medical, Plymouth, Minnesota, USA) probe will be placed over the head to measure cerebral blood flow.


Locations(1)

Westmead Hospital - Westmead

NSW, Australia

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