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Completed

NCT Number: NCT02944773

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

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.

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Key information

Conditions

Stress Body Weight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 day–9 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Silvia Vicente Pérez

Castelldefels, Barcelona, 08860, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Facilitated tucking device

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Spanish Clinical Research Network - SCReN

Registry information

Acronym: UTER

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 26, 2016
Registry last updated
Jan 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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