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

Premature Birth of Newborn Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02306317
• Other study ID #: Neonatología-2014-01
• Status: Recruiting
• Phase: N/A
• First received: December 1, 2014
• Last updated: March 14, 2018
• Start date: March 2014
• Est. completion date: June 2018

Study information

• Verified date: March 2018
• Source: Hospital Universitario 12 de Octubre
• Contact: Carmen R. Pallás Alonso, Dra.
• Phone: 34 913908272
• Email: carmenrosa.pallas[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 9 Months

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Premature Birth of Newborn

Intervention

Other:
• Standard procedure
FiO2 manually controlled by nursing
• Experimental procedure
FiO2 manually controlled by parents, after training.

Locations

Country	Name	City	State
Spain	Hospital Universitario 12 de Octubre	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Carmen Rosa Pallas	Hospital Universitario 12 de Octubre

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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