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Premature BirthFICareNCT01852695

Family Integrated Care in the NICU

A study testing Family Integrated Care in people with Premature Birth, run by Mount Sinai Hospital, Canada at 15 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In the highly technological environment of the modern neonatal intensive care unit (NICU), the infant is physically, psychologically and emotionally separated from its parents. Recognition that this impedes parent- infant interaction and is detrimental to the infant, led to the development of programs such as family… Read more about this study

Who is it for?
Ages Up to 33 weeks
Conditions the study is for
Premature Birth
What is being tested?
Family Integrated Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
720 participants
Where
15 sitesCanada
Study dates
Mar 2013to Mar 2017
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 Up to 33 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • < 33 weeks gestational age at birth;
  • On no respiratory support or low level respiratory support (i.e., oxygen by cannula or mask, or continuous positive airway pressure (CPAP);
  • A primary caregiver parent who is willing and able to commit to spending at least 8 hours per day with her/his infant between the hours of 0700 and 2000;
  • Parental consent.

Who cannot join

  • Palliative care;
  • Major life threatening congenital anomaly;
  • Critical illness (unlikely to survive);
  • On high level of respiratory support (mechanical ventilator, high frequency oscillatory or jet ventilation, extra-corporeal membrane oxygenation)
  • Parental request for early transfer to another hospital;
  • Parental inability to participate (e.g., health, social or language issues that might inhibit their ability to communicate with the healthcare team).

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Canada15 sites

  • Foothills Medical Centre

    Calgary, Alberta

  • IWK Health Centre

    Halifax, Nova Scotia

  • Hamilton Health Sciences Centre

    Hamilton, Ontario

  • Centre hospitalier universitaire de Québec

    Laval, Quebec

  • London Health Sciences Centre

    London, Ontario

  • The Moncton Hospital

    Moncton, New Brunswick

  • Regina General Hospital

    Regina, Saskatchewan

  • Saint John Regional Hospital

    Saint John, New Brunswick

  • Royal University Hospital

    Saskatoon, Saskatchewan

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec

  • Hospital for Sick Children

    Toronto, Ontario

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

  • Windsor Regional Hospital

    Windsor, Ontario

  • Health Sciences Centre, Winnipeg

    Winnipeg, Manitoba

  • St. Boniface General Hospital

    Winnipeg, Manitoba

Other trials in Canada

About this study

Official title: A Family Integrated Care Model For The Neonatal Intensive Care Unit: A Cluster Randomised Controlled Trial

In the highly technological environment of the modern neonatal intensive care unit (NICU), the infant is physically, psychologically and emotionally separated from its parents. Recognition that this impedes parent- infant interaction and is detrimental to the infant, led to the development of programs such as family centered care, kangaroo care and skin-to-skin care1-3. However, they are based on the common premise that only NICU professionals with special skills can provide care for the infant. Parents are relegated to a supportive role, and some have described themselves as voyeurs who are "allowed" to visit and hold their infants4. Many feel anxious and unprepared to care for their infants after discharge5.

In 1979, a shortage of NICU nurses in Estonia prompted Levin1,6 to implement a "humane" care model in which parents provided nursing care for the infant (except for administration of IV fluid and medication), while nurses provided teaching and guidance to parents. This resulted in 30% improvement in weight gain1,30% reduction in infections, 20% reduction in NICU length of stay, 50% reduction in nurse utilization and overall improved satisfaction among parents and staff [personal communication, Levin,A.]. Building on the Estonian experience, we have developed a new Family Integrated Care (FIC) model that is adapted for the NICU environment in North America. In a pilot study at Mount Sinai Hospital, Toronto 46 infants and their families were enrolled in the study. Preliminary results and feedback from parents and healthcare providers (HCP) show that the FIC model is both feasible and safe, and may lead to improved outcomes including improved weight gain(paper submitted for publication). This study is a cluster randomized controlled trial in 16 tertiary level NICUs, to evaluate the efficacy of the FIC model in Canada.

Conditions
Premature Birth
Being tested
Family Integrated Care
Keywords
Family integrated Care, Family centered care, NICU family centered care, NICU parent program
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family Integrated CareBehavioural

    Parents are integrated into the care of their infants in the NICU. Parents consent to spending up to eight hours a day with their infant, attend special education sessions, participate in daily medical rounds, and do basic infant charting. This will enable parents to provide care for infants with nursing supervision in the areas of feeding, bathing, dressing and holding skin to skin.

Study groups in NCT01852695
Study groupRoleWhat they receive
Family Integrated Care ArmExperimentalParents are integrated into the care of their infants in the NICU. Parents consent to spending up to eight hours a day with their infant, attend special education sessions, participate in daily medical rounds, and do basic infant charting. This will enable parents to provide care for infants with nursing supervision in the areas of feeding, bathing, dressing and holding skin to skin.
Receives: Behavioral: Family Integrated Care
Control ArmNo interventionRegular care by nurse will be provided to patients admitted to control sites.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight Gain

    Change in weight from enrollment to day 21 following commencement of the intervention

    Measured: Day 0-21

Secondary outcomes (6)

  1. Weight gain velocity

    Weight gain velocity at 21 days post-intervention commencement;

    Measured: Day 0-21

  2. Breastfeeding rate

    Participants will be followed until first discharge home from hospital, an expected average 13 weeks

    Measured: up to 16 weeks

  3. Clinical outcomes (mortality and Nosocomial infection (NI), Necrotizing Enterocolitis (NEC), Bronchopulmonary Dysplasia(BPD), Retinopathy of prematurity(ROP) & Intraventricular haemorrhage(IVH)

    Patients will be followed for the duration of their hospital stay for an expected average of 13 weeks. Mortality and five major morbidities: (a) Nosocomial infection will be defined using the Center for Disease Control criteria; (b) Necrotizing enterocolitis is defined using Bell's criteria;(c) Bronchopulmonary dysplasia is defined according to Shennan et al; (d) Intraventricular hemorrhage will be classified using the Canadian Pediatric Society classification, from cranial ultrasound performed during the first 28 days of life; (e) Retinopathy of prematurity will be staged according to the International Classification of Retinopathy of Prematurity.

    Measured: up to 16 weeks

  4. Safety

    Number of critical incident reports/1000 patient days

    Measured: 1000 patient days

  5. Parental stress and anxiety

    We will administer questionnaires to parents in the first week following admission and when their infant reaches 35 weeks corrected gestational age, in both the intervention and control sites

    Measured: Day 0 and when the infant reaches 35 weeks corrected gestational age

  6. Resource Use

    Data on health care utilisation will be collected during the patients entire hospital stay until the first discharge home, averaging 13 weeks including length of stay, duration of oxygen therapy. Per diem costs will be used to estimate potential cost savings derived from any reduced length of stay.

    Measured: Day 0 -week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionOct 2015
  4. Study completionMar 2017 (estimated)

Resources

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
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
720 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01852695
Sponsor's protocol ID
122173
Acronym
FICare
Status last verified
Oct 2015
First submitted
19 Dec 2012
Last updated
4 Oct 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Mclean MA, Scoten OC, Yu W, Ye XY, Petrie J, Church PT, Soraisham AS, Mirea LS, Weinberg J, Synnes AR, O'Brien K, Grunau RE. Lower Maternal Chronic Physiological Stress and Better Child Behavior at 18 Months: Follow-Up of a Cluster Randomized Trial of Neonatal Intensive Care Unit Family Integrated Care. J Pediatr. 2022 Apr;243:107-115.e4. doi: 10.1016/j.jpeds.2021.12.055. Epub 2021 Dec 29.

    PubMed 34971651

  • Synnes AR, Petrie J, Grunau RE, Church P, Kelly E, Moddemann D, Ye X, Lee SK, O'Brien K; Canadian Neonatal Network Investigators; Canadian Neonatal Follow-Up Network Investigators. Family integrated care: very preterm neurodevelopmental outcomes at 18 months. Arch Dis Child Fetal Neonatal Ed. 2022 Jan;107(1):76-81. doi: 10.1136/archdischild-2020-321055. Epub 2021 Jun 18.

    PubMed 34145042

  • O'Brien K, Robson K, Bracht M, Cruz M, Lui K, Alvaro R, da Silva O, Monterrosa L, Narvey M, Ng E, Soraisham A, Ye XY, Mirea L, Tarnow-Mordi W, Lee SK; FICare Study Group and FICare Parent Advisory Board. Effectiveness of Family Integrated Care in neonatal intensive care units on infant and parent outcomes: a multicentre, multinational, cluster-randomised controlled trial. Lancet Child Adolesc Health. 2018 Apr;2(4):245-254. doi: 10.1016/S2352-4642(18)30039-7. Epub 2018 Feb 8.

    PubMed 30169298

  • O'Brien K, Bracht M, Robson K, Ye XY, Mirea L, Cruz M, Ng E, Monterrosa L, Soraisham A, Alvaro R, Narvey M, Da Silva O, Lui K, Tarnow-Mordi W, Lee SK. Evaluation of the Family Integrated Care model of neonatal intensive care: a cluster randomized controlled trial in Canada and Australia. BMC Pediatr. 2015 Dec 15;15:210. doi: 10.1186/s12887-015-0527-0.

    PubMed 26671340

Questions about this trial

What is this clinical trial studying?

A study testing Family Integrated Care in people with Premature Birth, run by Mount Sinai Hospital, Canada at 15 sites 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites 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?

Results are not available in the source record.

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?

Weight Gain (time frame: Day 0-21). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01852695, which also lists 4 linked publications.

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 4 Oct 2016.

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