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

Stress Clinical Trial

— UTER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02944773
• Other study ID #: IIBSP-EST-2015-97
• Status: Completed
• Phase: N/A
• First received: October 10, 2016
• Last updated: January 23, 2018
• Start date: October 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 9 Days

Eligibility

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.

Related Conditions & MeSH terms

• Stress

Intervention

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

Locations

Country	Name	City	State
Spain	Silvia Vicente Pérez	Castelldefels	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	SCReN (Spanish Clinical Research Network)

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Behavioral signs	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