Assessment of Facilitated Tucking During the Procedure of Daily Weight on the Level of Stress in Preterm Infants (UTER)

January 23, 2018 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Randomized crossover clinical trial in which is intended to assess the effect of facilitated tucking of premature infants during daily weight. Heart rate, respiratory rate and neo-scale stress (ALPS-Neo) be observed before, during and one hour after the weight, and compared with normal practice, without facilitated tucking device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Population(n): 20 newborn When a patient is a possible candidate, consent will be asked their parents. After obtaining informed consent signed by parents, it will be assigned a random group (G1, G2). In the G1, the first weight without facilitated tucking device and the next day with facilitated tucking device will be held. G2 will be done in reverse.

Handling pre phase (T0): at least 20 minutes before vitals heart rate and respiratory rate are taken in five times.

handling phase (T1): 1. the facilitated tucking device is placed. 2. will wait five minutes and weight will be held in the incubator;at the time of leaving it in the incubator the same constants are taken.

post handling phase (T2): the same constants are taken one hour after such manipulation.

Study Type

Interventional

Enrollment (Actual)

20

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
    • Barcelona
      • Castelldefels, Barcelona, Spain, 08860
        • Silvia Vicente Pérez

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

5 days to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≤1500 grams newborns
  • a week of life about

Exclusion Criteria:

  • Surgery
  • Hemodynamic instability requiring vasoactive drugs
  • Sedation
  • Phototherapy at the time of the procedure
  • Congenital anomalies.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: facilitated tucking device (FTD)
20 infants use a FTD in the procedure of daily weight
Procedure: Facilitated tucking device
20 newborns are using a facilitated tucking device weight during the procedure to assess the level of stress
No Intervention: without FTD
20 infants use not a FTD in the procedure of daily weight

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate and breathing rate will be decreased compared to baseline measurement.
Time Frame: one year
Heart rate (beats / minute)and respiratory rate will decrease significantly during facilitated tucking weight.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral signs
Time Frame: one year
ALPS-Neo scale will decreased significantly during facilitated tucking weight. Evaluate the behaviors: facial expression, respiratory pattern, tone of limbs, activity of hands and feet, and level of activity collected on the scale ALPS-Neo during weight, and compare them with facilitated tucking weight
one year

Collaborators and Investigators

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

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Collaborators

Spanish Clinical Research Network - SCReN

Investigators

  • Principal Investigator: silvia Vicente Pérez, Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau

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)

October 1, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

October 10, 2016

First Submitted That Met QC Criteria

October 24, 2016

First Posted (Estimate)

October 26, 2016

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IIBSP-EST-2015-97

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

october 2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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