The Adding Value of Parents to Nursing Care in the Control of FiO2
NCT ID: NCT02306317
Last Updated: 2018-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
46 participants
INTERVENTIONAL
2014-03-31
2018-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Control by nursing.
FiO2 adjusted manually by nursing staff. Intervention: Other. Standard procedure
Standard procedure
FiO2 manually controlled by nursing
Control by parents.
FiO2 adjusted manually by parents. Intervention. Other. Experimental procedure
Experimental procedure
FiO2 manually controlled by parents, after training.
Interventions
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Standard procedure
FiO2 manually controlled by nursing
Experimental procedure
FiO2 manually controlled by parents, after training.
Eligibility Criteria
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Inclusion Criteria
* 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
* Non-compliance with study protocol.
* Requiring treatment with vasoactive drugs.
7 Days
9 Months
ALL
No
Sponsors
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Hospital Universitario 12 de Octubre
OTHER
Carmen Rosa Pallas
OTHER
Responsible Party
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Carmen Rosa Pallas
Dra. Carmen Rosa Pallás Alonso
Principal Investigators
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Carmen R. Pallás Alonso, Dra.
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario 12 de Octubre
Locations
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Hospital Universitario 12 de Octubre
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Carmen R. Pallás Alonso, Dra
Role: primary
M. Dolores Martín Pelegrina, Dra.
Role: backup
References
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Martin-Pelegrina MD, Lorenzo-Rodriguez A, Lora-Pablos D, Munoz-Amat B, Morales-Betancourt C, Pallas-Alonso CR. FiO2 control by parents of preterm infants admitted to a neonatal intensive care unit: A pilot study. Acta Paediatr. 2018 Aug;107(8):1471-1472. doi: 10.1111/apa.14364. Epub 2018 May 11. No abstract available.
Other Identifiers
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Neonatología-2014-01
Identifier Type: -
Identifier Source: org_study_id
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