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

Not Applicable

Completed

• Conditions: Stress
• Interventions: Procedure: Facilitated tucking device

• Registration Number: NCT02944773
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-10
• Study First Submitted QC: 2016-10-24
• Study First Posted: 2016-10-26
• Primary Completion: 2017-10
• Status Verified: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
facilitated tucking device (FTD)	Facilitated tucking device	20 infants use a FTD in the procedure of daily weight

Primary Outcome Measures

Name	Time	Method
Heart rate and breathing rate will be decreased compared to baseline measurement.	one year	Heart rate (beats / minute)and respiratory rate will decrease significantly during facilitated tucking weight.

Secondary Outcome Measures

Name	Time	Method
Behavioral signs	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

Trial Locations

Locations (1)

Silvia Vicente Pérez; 🇪🇸 Castelldefels, Barcelona, Spain