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Trial record 3 of 14 for:    PALLAS

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 : October 24, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Premature Birth of Newborn Other: Standard procedure Other: Experimental procedure

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
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
Study Start Date : March 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016
Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. Percentage of time the child is kept within the ranges of saturation in each group [ Time Frame: 20-40 hours as maximum ]

Eligibility Criteria

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Ages Eligible for Study:   up to 9 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

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 913908272 carmenrosa.pallas@salud.madrid.org
Contact: M. Dolores Martín Pelegrina, Dra. 34 913908272 mariadolores.martinp@salud.madrid.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      
Sponsors and Collaborators
Carmen Rosa Pallas
Hospital Universitario 12 de Octubre
Principal Investigator: Carmen R. Pallás Alonso, Dra. Hospital Universitario 12 de Octubre
More Information

Responsible Party: Carmen Rosa Pallas, Dra. Carmen Rosa Pallás Alonso, Hospital Universitario 12 de Octubre
ClinicalTrials.gov Identifier: NCT02306317     History of Changes
Other Study ID Numbers: Neonatología-2014-01
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: October 24, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications