NCT02306317

The Adding Value of Parents to Nursing Care in the Control of FiO2

Changing the Paradigm for Improving Neonatal Care: Clinical Study on Optimal Oxygen-saturation Time and the Adding Value of Parents to Nursing Care in the Control of Fi02

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Carmen Rosa Pallas · Academic / Other
• Sex: All
• Age: 7 Days – 9 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether saturation control by parents in children younger than 32 weeks or under 1500 g versus conventional care performed by nursing increases the time in which these patients remain at optimal saturation range. If the hypothesis of this study is confirmed premature infants could prevent episodes of hypoxia-hyperoxia and also give more relevance to the role of parents in caring for their children admitted in a neonatal intensive care unit.

Detailed description

Both episodes of hyperoxia and hypoxemia in preterm infants increase morbidity and mortality. Nowadays the adjustment of FiO2 is manually controlled, which means it depends on the staff, needing multiple adjustments throughout the day. The investigators's hypothesis is that the FiO2 control by parents, improve the percentage of time in range of optimum saturation at least 10% compared to control by nurses. The aim of this study is to compare the proportion of time with oxygen saturation (SpO2) within the assigned target range, in the preterm infants whose parents modify the fraction of inspired oxygen (FiO2) versus the nursing staff modifying group. This is a randomized controlled clinical study in the neonatal intensive care unit at Hospital 12 de Octubre. Patients will be randomized in two groups, Experimental Group: parents controlling the saturation ranges, they will manually adjust FiO2 versus the Control Group: controlled by nursing staff (standard procedure). Saturations will be registered and adjustments of FiO2 will be filmed for nonconsecutive 20-hours periods. Twenty-three patients will be enrolled in each group.

Conditions

• Premature Birth of Newborn

Interventions

Type	Name	Description
OTHER	Standard procedure	FiO2 manually controlled by nursing
OTHER	Experimental procedure	FiO2 manually controlled by parents, after training.

Timeline

• Start date: 2014-03-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2014-12-03
• Last updated: 2018-03-15

Locations

1 site across 1 country: Spain