An interventional study of Family Integrated Care in Preterm Birth, Prematurity and Infant,Premature, sponsored by University of Calgary. Completed at 1 site in Canada. Open to female participants. Per ClinicalTrials.gov, last updated 2019-04-17.
Sponsored by University of Calgary · Not applicable, Interventional, and Health services research
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Among 11 studies in Premature Birth by University of Calgary — none open to participants now, none under way, none of them phase 3. Premature Birth · University of Calgary.
Among the 11 studies in Premature Birth by University of Calgary, this one is the only one that started in 2018, is one of 8 with no phase, and was the 9th registered.
2,554 studies on the registry are indexed under Premature Birth; 503 are open to participants now.
Browse Premature Birth studies →None of the 11 studies in Premature Birth by University of Calgary is open now. The open studies under Premature Birth, anywhere →
Of the 315 Premature Birth studies recruiting now, 88 (28%) set no upper age limit and 223 (71%) stop at 75 or younger; 241 take children under 18; 105 take healthy volunteers.
This study: female · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 56 is below the median of 84 across 1,670 interventional studies indexed under Premature Birth.
Median enrollment 99 across the 8 interventional studies, 144 across the 3 observational. Of the 11 that completed or were terminated, 1 (9%) have results posted.
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University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Premature Birth by University of Calgary, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The aim of this novel health services research proposal is to assess the longer-term outcomes, to 6 months corrected age, of an adapted Family Integrated Care (FICare) model of care for moderate and late preterm infants admitted to a Level II neonatal intensive care unit (NICU).
This follow-up study will enroll infants at 6 months CA (± 1 month) recruited to the original FICare randomized controlled trial (clinicaltrials.gov ID: NCT02879799) from four level II NICU sites; two intervention and two control.
The aim of this novel health services research proposal is to assess the longer-term outcomes, to 6 months corrected age, of Family Integrated Care (FICare) for moderate and late preterm infants admitted to a Level II neonatal intensive care unit (NICU). FICare is a psycho-educational intervention that empowers parents (mothers and fathers) to sequentially build their knowledge, skill, and confidence so the family is well-prepared to care for their preterm infant before discharge. FICare is dynamic, whereby parents and healthcare providers openly and mutually negotiate equitable caregiving roles during the infant's NICU stay. Parents are educated and coached to provide routine non-medical care. Healthcare providers continue to provide medical and technical care, such as intravenous medications and procedures, legal documentation, and professional support for families. Using a cluster randomized controlled trial (cRCT), our team is evaluating FICare in all 10 Level II NICUs in Alberta (5 intervention, 5 control sites; stratified by hospital size) with follow-up of infant development and costs at age 2 months corrected age (CA). Unless otherwise indicated, infant ages are corrected for prematurity. For the cRCT, we hypothesized that FICare would reduce length of NICU stay by 10%, reduce infant morbidities (e.g., nosocomial infections, respiratory support, feeding problems), increase breast-milk feeding, reduce maternal psychological distress, and reduce costs to the health care system and families. Maternal and infant data are currently being collected (1) shortly after admission to the NICU (baseline), (2) shortly before discharge from NICU (outcome), and (3) at 2 months CA (follow-up). At 2 months CA, our team will evaluate outcomes related to infant global development and maternal psychosocial distress. A follow-up study at 6 months CA will provide evidence of the sustainability of any effects, upon which to inform policy decisions about full-scale implementation of FICare in Level II NICUs.
There is currently no standardized timeline for follow-up of infants born prematurely. Follow-up at 6 months CA is appropriate as the utility of assessing development in preterm infants is questionable prior to this age, and evidence suggests that inter-individual variability in child development increases after 12 months. After 12 months, it becomes more difficult to capture parent-child interactions and environmental factors may exert a stronger influence on infant development, potentially diluting the ability to directly measure the effect of FICare.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study participants receive FICare, a dynamic psycho-educational intervention, while their infant(s) was/were admitted to a Level II NICU.
Behavioral: Family Integrated Care
Study participants received standard care while their infant(s) was/were admitted to a Level II NICU.
FICare is a dynamic psycho-educational intervention. The goal of FICare is a change in culture and practice that permits, encourages and supports parents in their parenting role while their infant is receiving health care in a Level II NICU. Underpinned by adult learning and change theories, FICare empowers parents to build their knowledge, skill and confidence so that the family is well-prepared to care for their infant long before discharge.
Maternal-Child Interactions
We will measure maternal-child interactions using the Parent-child interaction Teaching Scale (PCITS) to code video-taped structured play sessions of mothers with their infants. The PCITS is the most widely used macro-level, binary observational measure of the presence or absence of dyadic behaviours. The parent total (50 items; possible score of 50) is the sum of subscales: Sensitivity to Cues, Response to Distress, Social-Emotional Growth Fostering, and Cognitive Growth Fostering. The child total (23 items; possible score of 23) is the sum of subscales: Responsiveness to Caregiver and Clarity of Cues. Higher scores indicate more optimal interactions. It has been validated with preterm infants.
Time frame: At 6-months corrected age
Infant global development
Ages and Stages Questionnaire, 3rd edition: developmental screening instrument consists of 21 age-appropriate (1 to 66 months of age) questionnaires, with 30 items each. Assesses development in 5 domains: communication, gross motor, fine motor, problem-solving, and personal-social, each consisting of 6 items. Responses for each item receive a score of 0, 5, or 10 points. Item scores are summed for a total score with a possible range of 0 to 60 for all domains. Higher scores indicate more optimal child development. Based on empirically derived cut-offs, each domain total score is classified as (a) appropriate development, (b) monitoring zone (≥1 and \< 2 standard deviations below the mean), and (c) need for referral (2 standard deviations below the mean). The ASQ-3 has strong psychometric properties, including high sensitivity (0.86) and specificity (0.85), and has been evaluated and recommended as an effective screener of global development in moderate and late preterm infants
Time frame: At 6-months corrected age
Infant social and emotional development
Ages and Stages Questionnaire:Social-Emotional, 2nd edition: Screening instrument focused specifically on the social-emotional development of infants and young children, consisting of 9 age-appropriate (1 to 72 months of age) questionnaires. Scale at 18-months consists of 31 items, each receives a score of 0, 5, 10, or 15 points. Item scores are summed for a total score with a possible range of 0 to 465 (score of 105 represents 90th percentile). Lower total scores indicate more optimal social-emotional development. Based on empirically derived cut-offs, the total score is classified as (a) appropriate social-emotional development (below 65th percentile), (b) monitoring zone (between 65th percentile and referral cut-off), and (c) need for referral (above referral cut-off; around 80th percentile, depending on age interval). Test-retest reliability (0.89) and internal consistency reliability (0.84) are high, as are overall sensitivity (81%) and specificity (84%).
Time frame: At 6-months corrected age
Maternal-reported infant sleep
Extended Brief Infant Sleep Questionnaire (EBISQ): As the EBISQ is not a psychometric scale, no composite score is calculated, nor are there sub-scale. The scale contains 32 items capturing information on infant sleep patterns, sleep ecology, and caregiver perceptions; response categories include numerical (time, frequency count of night wakings), categorical (sleep location, bedtime activities) and ordinal rankings (how much of a problem is your baby's sleep? A large problem, a small problem, or no problem). No numerical values are assigned to items with ordinal or categorical answers. The EBISQ has been validated against actigraphy and daily-logs and its sensitivity in documenting expected developmental changes in infant sleep and the effects of environmental factors has been established.
Time frame: At 6-months corrected age
Maternal parenting self-efficacy
Perceived Maternal Parenting Self-Efficacy Scale: A 20 item self-report measure of maternal parenting self-efficacy, scored on a 4-point Likert scale. The total score is calculated as a sum of responses to all 20 questions. Mothers can score between 20 - 80 overall, where the higher the score the higher the self-efficacy. Four subscales reflect different aspects of parenting, however; there are no cut-off scores.
Time frame: At 6-months corrected age
Breastfeeding rates
Breastfeeding questionnaire: a non-pscyhometric questionnaire will evaluate breastfeeding rates with questions asking if participants are breastfeeding, frequency of breastfeeding, and if participants are not breastfeeding, we ask infant's age at weaning and why breastfeeding was stopped.
Time frame: At 6-months corrected age
Number of emergency room visits
Provincial healthcare administrative databases
Time frame: At 6-months corrected age
Number of re-admissions to hospital
Provincial healthcare administrative databases
Time frame: At 6-months corrected age
Number of unplanned visits to physician or other provider
Provincial healthcare administrative databases
Time frame: At 6-months corrected age
Number of antibiotic prescriptions
This data will be collected in two ways: 1) maternal self-report as part of a study questionnaire, and 2) from the patient chart as collected by Alberta Health Services (AHS), the provincial healthcare provider in Alberta, Canada. A data disclosure agreement has been executed such that AHS Analysts with the Analytics, Data Integration, Measurement \& Reporting (DIMR) team will link FICare data with fields related to the number antibiotic prescriptions in AHS data holdings. The specific variables related to this outcome will be selected for and identified in consultation with AHS Analysts who have extensive knowledge of their metadata.
Time frame: At 6-months corrected age
Direct industry costs (hospital costs, excluding housekeeping, maintenance, planning and physician times).
Provincial healthcare administrative databases
Time frame: At 6-months corrected age
Parenting stress
Parenting Stress Index - Short Form - 4th edition (PSI-SF-4): A 36-item scale, captures general parenting stress and three subscales of Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Responses 1, 2, 3, 7, 8, 9 and 11 are summed for Defensive Responding. Subscale scores are calculated by summing response items 1-12 for Parental Distress, items 13 - 24 for Parent-Child Dysfunctional Interaction, and items 25 - 36 for Difficult Child. Total Stress score is calculated by summing the raw scores of the subscales. Raw scores are converted to T scores and percentiles. Normal range for scores is within the 16th to 84th percentiles. Scores in the 85th to 89th percentile are considered high, and scores in the 90th percentile or higher are considered clinically significant.
Time frame: At 6-months corrected age
State Anxiety
State-Trait Anxiety Inventory (STAI): Two sub-scales: 1) long-standing quality of trait anxiety (20 items), and 2) the temporary condition of state anxiety (20 items). Items are rated on a 4-point scale. Item scores are added to obtain subtest total scores. Scoring is reversed for anxiety-absent items (19/40 items). Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the state anxiety scale. Normative values are available in the manual. Trait anxiety was collected previously in the FICare cRCT (NCT02879799) therefore, only state anxiety will be collected at 6 months.
Time frame: At 6-months corrected age
Postnatal depression risk
Edinburgh Postnatal Risk Depression (EPDS) scale: A 10 item, 4-point Likert scale, self-report measure of postnatal depression. The total score is calculated as a sum of responses to all 10 questions. Questions 1, 2 and 4 are reverse scored. The range of possible scores are: 1) 0-9; indicates presence of some symptoms of distress that may be short-lived and less likely to interfere with day to day ability to function, 2) 10 - 12; indicate presence of symptoms of distress that may be discomforting, and 3) 13+; requires further assessment and appropriate management as likelihood of depression is high. Referral to professional supports may be necessary. Any woman scoring 1+ on item 10 requires further evaluation to ensure her own safety and that of her baby/babies.
Time frame: At 6-months corrected age
Plan to share: Yes — Discussions are underway to draft a data deposition agreement with Secondary Analyses to Generate Evidence (SAGE).
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Mar 2019, 13 months.
Of 744 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 13 months is below that.
Counting every sponsor, half of 762 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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