The Adding Value of Parents to Nursing Care in the Control of FiO2
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|ClinicalTrials.gov Identifier: NCT02306317|
Recruitment Status : Recruiting
First Posted : December 3, 2014
Last Update Posted : March 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Premature Birth of Newborn||Other: Standard procedure Other: Experimental procedure||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||March 2014|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Active Comparator: Control by nursing.
FiO2 adjusted manually by nursing staff. Intervention: Other. Standard procedure
Other: Standard procedure
FiO2 manually controlled by nursing
Experimental: Control by parents.
FiO2 adjusted manually by parents. Intervention. Other. Experimental procedure
Other: Experimental procedure
FiO2 manually controlled by parents, after training.
- Children maintained within the saturation ranges in each group [ Time Frame: 20-40 hours as maximum ]Percentage of time the child is kept within the ranges of saturation in each group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02306317
|Contact: Carmen R. Pallás Alonso, Dra.||34 email@example.com|
|Contact: M. Dolores Martín Pelegrina, Dra.||34 firstname.lastname@example.org|
|Hospital Universitario 12 de Octubre||Recruiting|
|Madrid, Spain, 28041|
|Contact: Carmen R. Pallás Alonso, Dra 34 913908272|
|Contact: M. Dolores Martín Pelegrina, Dra. 34 913908272|
|Principal Investigator:||Carmen R. Pallás Alonso, Dra.||Hospital Universitario 12 de Octubre|