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

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ClinicalTrials.gov Identifier: NCT02944773
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : January 24, 2018
Sponsor:
Collaborator:
Spanish Clinical Research Network - CAIBER
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stress Procedure: Facilitated tucking device Not Applicable

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  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Assessment of Facilitated Tucking During the Procedure of Daily Weight on the Level of Stress in Preterm Infants
Actual Study Start Date : October 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



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

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.

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): NCT02944773


Locations
Spain
Silvia Vicente Pérez
Castelldefels, Barcelona, Spain, 08860
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Spanish Clinical Research Network - CAIBER
Investigators
Principal Investigator: silvia Vicente Pérez Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau

Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02944773     History of Changes
Other Study ID Numbers: IIBSP-EST-2015-97
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: october 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
newborn
facilitated tucking
position
weight
stress