Premature Baby 26 to 32 WeeksNCT03490721
Effects of Clustering Care on the Physiological Stability of Preterm Infants.
A study testing Clustering care in people with Premature Baby 26 to 32 Weeks, run by Université de Montréal at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 26 to 32 weeks
- Conditions the study is for
- Premature Baby 26 to 32 Weeks
- What is being tested?
- Clustering care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 12 Sep 2018to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Clustering Care on the Physiological Stability of Preterm Infants in a Neonatal Intensive Care Unit.
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.
Read the detailed 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.
- Conditions
- Premature Baby 26 to 32 Weeks
- Being tested
- Clustering care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clustering careOther
During 20 minutes, preterm infants will receive a cluster care with 2 minutes of hand containment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Clustering care for 20 minutes. Receives: Other: Clustering care |
| Control | No intervention | Standard care non clustered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: The physiological stability will be measured for 70 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start12 Sep 2018
- Primary completion3 Apr 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Baby 26 to 32 WeeksStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abril Nicole Fernandez Oviedo, Université de Montréal
- Investigators
- Marilyn Aita, PhD, Study director, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490721
- Sponsor's protocol ID
- Etude_maitrise_2018
- Status last verified
- Jan 2020
- First submitted
- 23 Mar 2018
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results of this project could be made public in a journal or scientific congress.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Clustering Care on the Physiological Stability of Preterm Infants in a Neonatal Intensive Care Unit.
- ClinicalTrials.gov ID
- NCT03490721
- Acronym / sponsor ID
- Etude_maitrise_2018
- Conditions
- Premature Baby 26 to 32 Weeks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Clustering careClustering care for 20 minutes. |
| Control | No intervention | –Standard care non clustered. |
Who may qualify
- Ages
- 26 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clustering careDuring 20 minutes, preterm infants will receive a cluster care with 2 minutes of hand containment. | Other | Intervention |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: Yes. The results of this project could be made public in a journal or scientific congress.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marilyn Aita, PhD study director
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clustering care in people with Premature Baby 26 to 32 Weeks, run by Université de Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological stability (heart rate, respiratory rate and oxygen saturation) (time frame: The physiological stability will be measured for 70 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.