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

Premature Baby 26 to 32 Weeks Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03490721
• Other study ID #: Etude_maitrise_2018
• Status: Completed
• Phase: N/A
• Start date: September 12, 2018
• Est. completion date: May 30, 2019

Study information

• Verified date: January 2020
• Source: Université de Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 30, 2019
• Est. primary completion date: April 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Weeks to 32 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Premature Baby 26 to 32 Weeks

Intervention

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

Locations

Country	Name	City	State
Canada	Jewish General Hospital	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physiological stability (heart rate, respiratory rate and oxygen saturation)	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).	The physiological stability will be measured for 70 minutes.