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Effects of Clustering Care on the Physiological Stability of Preterm Infants.

U

Université de Montréal

Status

Completed

Conditions

Premature Baby 26 to 32 Weeks

Treatments

Other: Clustering care

Study type

Interventional

Funder types

Other

Identifiers

NCT03490721
Etude_maitrise_2018

Details and patient eligibility

About

This crossover design experimental study aims to compare the physiological stability of premature newborns during and after a cluster of care compared to a period when they receive standard non clustered care at the neonatal unit.

Full description

The cluster care will take place at the time of feeding of the premature infants. The intervention will start with a calm period of 20 minutes before the start of care (no manipulations will be allowed), the baby will then received the cluster care for 20 minutes and a quiet period of 30 minutes will follow after the cluster care.

Enrollment

10 patients

Sex

All

Ages

26 to 32 weeks old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • between 26 to 31 6/7 weeks of gestation at birth
  • more than 72 hours of life,
  • receive a respiratory aid such as endotracheal tube, NIPPV (non invasive positive pressures ventilation), CPAP (continuous positive airway pressure) or nasal prongs with oxygen,
  • are fed intravenously (IV) or by central venous catheter (CVC),
  • one of the parents speaks and reads English or French,
  • one of the parents is at least 18 years old to sign the consent.

Exclusion criteria

  • severely ill (necrotizing enterocolitis, septicemia),
  • under respiratory assistance or on a high frequency mode,
  • having a congenital or cardiac abnormality,
  • requiring surgery,
  • sedatives or opioids,
  • diagnosed with grade II, III or IV intraventricular hemorrhage and / or hydrocephalus,
  • have a device for invasive blood pressure,
  • having an oxygen requirement of more than 30% to maintain oxygen saturation within the limits indicated by the NICU (neonatal intensive care unit).
  • one of the parents is at least 18 years old to sign the consent.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

10 participants in 2 patient groups

Intervention
Experimental group
Description:
Clustering care for 20 minutes.
Treatment:
Other: Clustering care
Control
No Intervention group
Description:
Standard care non clustered.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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