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

Carmen Rosa Pallas

Status: Unknown

Conditions: Premature Birth of Newborn

Treatments: Other: Standard procedure; Other: Experimental procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT02306317

Neonatología-2014-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 estimated patients

Sex: All

Ages: 7 days to 9 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Control by nursing.

Active Comparator group

Description:

FiO2 adjusted manually by nursing staff. Intervention: Other. Standard procedure

Treatment:

Other: Standard procedure

Control by parents.

Experimental group

Description:

FiO2 adjusted manually by parents. Intervention. Other. Experimental procedure

Treatment:

Other: Experimental procedure