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

March 14, 2018 updated by: Carmen Rosa Pallas

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
          • Carmen R. Pallás Alonso, Dra
          • Phone Number: 34 913908272
        • Contact:
          • M. Dolores Martín Pelegrina, Dra.
          • Phone Number: 34 913908272

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
20-40 hours as maximum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmen Rosa Pallas

Collaborators

Hospital Universitario 12 de Octubre

Investigators

  • Principal Investigator: Carmen R. Pallás Alonso, Dra., Hospital Universitario 12 de Octubre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

December 1, 2014

First Submitted That Met QC Criteria

December 2, 2014

First Posted (Estimate)

December 3, 2014

Study Record Updates

Last Update Posted (Actual)

March 15, 2018

Last Update Submitted That Met QC Criteria

March 14, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neonatología-2014-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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