RecruitingACTRN12623001037695

Maternal OXygen Immediately before birth: The MOXIE feasibility study


Sponsor

Douglas Blank

Enrollment

45 participants

Start Date

Oct 9, 2024

Study Type

Interventional

Conditions

Summary

We aim to determine if maternal oxygen supplementation 5-10 min prior to birth of term and near-term infants (32 weeks gestation or above at birth) utilising heated humidified high flow nasal cannula with 100% oxygen at 30-70L/min is feasible at both caesarean section and vaginal births. The information gained from this feasibility study will inform the planned randomised controlled trial of maternal oxygen in very preterm infants.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

Premature and near-term babies can sometimes need extra support with breathing and oxygen levels in the minutes immediately after birth — a critical window when medical teams need to act quickly. This feasibility study, called MOXIE, is exploring whether giving the mother extra oxygen through a high-flow nasal cannula just before delivery can improve the baby's oxygen levels at birth and reduce the need for resuscitation. This is a small feasibility study, meaning its primary goal is to test whether the approach is safe and practical to use during both caesarean sections and vaginal births before a larger trial is designed. Researchers will track how well mothers tolerate the oxygen delivery method and observe the oxygen levels of newborns in the minutes after birth. You may be eligible if you are pregnant and due to give birth between 32 and 41 weeks and 6 days of pregnancy. Women with certain nasal or sinus conditions, severe COPD exacerbation, or whose baby has specific congenital heart conditions are not eligible. The study is led by Dr Douglas Blank.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Maternal oxygen supplementation via heated humidified high flow nasal cannula for 5-10 minutes at 100% oxygen at 30-70L/min before umbilical cord is clamped. Adherence will be monitored in person by o

Maternal oxygen supplementation via heated humidified high flow nasal cannula for 5-10 minutes at 100% oxygen at 30-70L/min before umbilical cord is clamped. Adherence will be monitored in person by one of two principal investigators and will be documented in study database


Locations(1)

Monash Medical Centre - Clayton campus - Clayton

VIC, Australia

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ACTRN12623001037695