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Completed

NCT Number: NCT03490721

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

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.

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Key information

Conditions

Premature Baby 26 to 32 Weeks

Age range

26 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Clustering care

Other

During 20 minutes, preterm infants will receive a cluster care with 2 minutes of hand containment.

Primary outcomes

  1. Physiological stability (heart rate, respiratory rate and oxygen saturation)

    Time frame: The physiological stability will be measured for 70 minutes.

    The physiological stability will be measured with the SCRIP score. The Stability of the cardiorespiratory system in premature infants is a scale, in which a score of 0 means major physiological instability and a score of 6 means a physiological stability. For every single parameter there's three grades from severe instability (0 points) to minor instability (1 point) to perfect stability (2 points).

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Registry information

Official study title

Effects of Clustering Care on the Physiological Stability of Preterm Infants in a Neonatal Intensive Care Unit.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 6, 2018
Registry last updated
Jan 18, 2020

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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