NCT02944773

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 24, 2018

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

October 10, 2016

Last Update Submit

January 23, 2018

Conditions

Stress

Keywords

newbornfacilitated tuckingpositionweightstress

Outcome Measures

Primary Outcomes (1)

  • Heart rate and breathing rate will be decreased compared to baseline measurement.

    Heart rate (beats / minute)and respiratory rate will decrease significantly during facilitated tucking weight.

    one year

Secondary Outcomes (1)

  • Behavioral signs

    one year

Study Arms (2)

facilitated tucking device (FTD)

EXPERIMENTAL

20 infants use a FTD in the procedure of daily weight

Procedure: Facilitated tucking device

without FTD

NO INTERVENTION

20 infants use not a FTD in the procedure of daily weight

Interventions

Facilitated tucking devicePROCEDURE

20 newborns are using a facilitated tucking device weight during the procedure to assess the level of stress

facilitated tucking device (FTD)

Eligibility Criteria

Age5 Days - 9 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ≤1500 grams newborns
  • a week of life about

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Silvia Vicente Pérez

Castelldefels, Barcelona, 08860, Spain

Location

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • silvia Vicente Pérez

    Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2016

First Posted

October 26, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

January 24, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

october 2017

Locations

ES(1)