NCT02306317

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

March 15, 2018

Status Verified

March 1, 2018

Enrollment Period

4.3 years

First QC Date

December 1, 2014

Last Update Submit

March 14, 2018

Conditions

Premature Birth of Newborn

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Control by nursing.

ACTIVE COMPARATOR

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

Other: Standard procedure

Control by parents.

EXPERIMENTAL

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

Other: Experimental procedure

Interventions

Standard procedureOTHER

FiO2 manually controlled by nursing

Control by nursing.
Experimental procedureOTHER

FiO2 manually controlled by parents, after training.

Control by parents.

Eligibility Criteria

Age7 Days - 9 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Evidence of pneumothorax or pneumomediastinum.
  • Non-compliance with study protocol.
  • Requiring treatment with vasoactive drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29676033DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Carmen R. Pallás Alonso, Dra.

    Hospital Universitario 12 de Octubre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen R. Pallás Alonso, Dra.

CONTACT

34 913908272carmenrosa.pallas@salud.madrid.org

M. Dolores Martín Pelegrina, Dra.

CONTACT

34 913908272mariadolores.martinp@salud.madrid.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dra. Carmen Rosa Pallás Alonso

Study Record Dates

First Submitted

December 1, 2014

First Posted

December 3, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

March 15, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)