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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Premature Birth of Newborn

Intervention / Treatment
-----------------
* Other: Standard procedure
* Other: Experimental procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Related to child Preterm neonates less than 32 weeks or less than 1500 g hospitalized in the Neonatal Intensive Care Unit at Hospital 12 de Octubre. Receiving supplemental oxygen ≤0.4 administered by CPAP or conventional nasal cannula or high flow or children with BiPAP (flow generator with double level pressure) Minimum age 7 days old. Related to the mother: Absence of health problems that allows her to perform the task. Availability to frequently visit her baby with the father or with a companion, at least for 20 hours, not consecutive. Understanding of the study and the Spanish language by the mother and father or companion. Signed informed consent. Exclusion Criteria: Evidence of pneumothorax or pneumomediastinum. Non-compliance with study protocol. Requiring treatment with vasoactive drugs.

Ages Eligible for Study
-----------------
Minimum Age: 7 Days
Maximum Age: 9 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control by nursing.<br>FiO2 adjusted manually by nursing staff. Intervention: Other. Standard procedure | Other: Standard procedure<br>* FiO2 manually controlled by nursing<br>|
| Experimental: Control by parents.<br>FiO2 adjusted manually by parents. Intervention. Other. Experimental procedure | Other: Experimental procedure<br>* FiO2 manually controlled by parents, after training.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children maintained within the saturation ranges in each group | Percentage of time the child is kept within the ranges of saturation in each group | 20-40 hours as maximum |