A Cluster Randomized Controlled Trial of FICare At 18 Months

NCT03337659 | Completed

• 1 other identifier: CIP-150740
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 1

Brief Summary

In Alberta, one in every twelve babies is born preterm. Compared with their full term counterparts, preterm infants who survive are at higher risk for respiratory problems, jaundice, infections, feeding problems, behavioural problems, and neuro-developmental disabilities, including cognitive delays, and visual and hearing impairments. As a result, parents must leave their preterm babies in the hospital to fully develop enough to care for them at home. When it is time for discharge, parents are often unprepared to look after their baby because they may have limited involvement in the care of their baby in hospital. In addition to the distress and costs to parents of having a baby in hospital, health system costs are also increased the longer a baby is in hospital. The aim of this novel health services study is to assess the longer-term outcomes and costs, to 18 months corrected age, of Family Integrated Care (FICare) for moderate and late preterm infants admitted to a Level II neonatal intensive care unit (NICU). A cluster randomized controlled trial (cRCT) of FICare is currently in progress. 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. The FICare cRCT evaluates outcomes related to infant global development and maternal psychosocial distress at 2 months. At 2 months, it is difficult to predict longer term outcomes for moderate and late preterm infants. A follow-up study at 18 months will provide evidence of the sustainability of any effects, and longer-term cost savings upon which to inform policy decisions about full-scale implementation of FICare in Level II NICUs.

Conditions

Premature Birth

Keywords

Family-integrated care; neonatal intensive care unit; premature; infant development

Outcome Measures

Primary Outcomes (1)

• Global development

  Ages and Stages Questionnaire, 3rd edition

  At 18-months corrected age

Secondary Outcomes (11)

• Infant social and emotional development

  At 18-months corrected age

• Number of emergency room visits

  At 18-months corrected age

• Number of re-admissions to hospital

  At 18-months corrected age

• Number of unplanned visits to physician or other provider

  At 18-months corrected age

• Number of antibiotic prescriptions

  At 18-months corrected age

Study Arms (2)

FICare Intervention Group

EXPERIMENTAL

Study participants received Family Integrated Care (intervention) while their infant(s) was/were admitted to a Level II NICU.

Other: Family Integrated Care

FICare Control Group

NO INTERVENTION

Study participants received standard care while their infant(s) was/were admitted to a Level II NICU.

Interventions

Family Integrated Care OTHER

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.

Also known as: FICare

FICare Intervention Group

Eligibility Criteria

• Age: 18 Months+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Mothers of infants born between 32 weeks and zero days and 34 weeks and 6 days gestation who enrolled in the FICare Alberta Level II NICU cluster controlled trial (cRCT). The FICare cRCT enrolled mothers of any age who have decision making capacity; mothers who are able to speak, read and understand English well enough to provide informed consent, and complete surveys online or via telephone.

You may not qualify if:

• The FICare Alberta Level II NICU cRCT excluded mothers whose infants have serious congenital or chromosomal anomalies that require surgery, or are receiving palliative care; mothers who are not able to communicate in English; mothers with complex social issues.

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• University of Toronto: collaborator
• University of Alberta: collaborator
• Alberta Health services: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N1N4, Canada

Location

Related Publications (53)

• O'Brien K, Bracht M, Macdonell K, McBride T, Robson K, O'Leary L, Christie K, Galarza M, Dicky T, Levin A, Lee SK. A pilot cohort analytic study of Family Integrated Care in a Canadian neonatal intensive care unit. BMC Pregnancy Childbirth. 2013;13 Suppl 1(Suppl 1):S12. doi: 10.1186/1471-2393-13-S1-S12. Epub 2013 Jan 31.

  PMID: 23445639 BACKGROUND

• Benzies KM. Relational Communications Strategies to Support Family-Centered Neonatal Intensive Care. J Perinat Neonatal Nurs. 2016 Jul-Sep;30(3):233-6. doi: 10.1097/JPN.0000000000000195.

  PMID: 27465456 BACKGROUND

• Brown J, Ritchie JA. Nurses' perceptions of parent and nurse roles in caring for hospitalized children. Child Health Care. 1990 Winter;19(1):28-36. doi: 10.1207/s15326888chc1901_4.

  PMID: 10106396 BACKGROUND

• Mento G, Nosarti C. The case of late preterm birth: sliding forwards the critical window for cognitive outcome risk. Transl Pediatr. 2015 Jul;4(3):214-8. doi: 10.3978/j.issn.2224-4336.2015.06.02.

  PMID: 26835378 BACKGROUND

• Hack M, Wilson-Costello D. Follow-up outcomes of high risk infants. In: Buonocore G, Bracci R, Weindling M, eds. Neonatology: A practical approach to neonatal diseases: Springer; 2012:122-129.

  BACKGROUND

• March of Dimes, PMNCH, Save the Children, WHO. Born too soon: The global action report on preterm birth. Geneva: World Health Organization;2012.

  BACKGROUND

• World Health Organization. Preterm birth fact sheet. 2015; www.who.int/mediacentre/factsheets/fs363/en.

  BACKGROUND

• Alberta Health and Wellness. Interactive Health Data Application, 2015 reproductive health data set. 2015; www.ahw.gov.ab.ca/IHDA_Retrieval/selectSubCategoryParameters.do#.

  BACKGROUND

• Canadian Institute for Health Information. Highlights of 2010-2011 selected indicators describing the birthing process in Canada. Canadian Institute for Health Information;2012.

  BACKGROUND

• Tough SC, Newburn-Cook C, Johnston DW, Svenson LW, Rose S, Belik J. Delayed childbearing and its impact on population rate changes in lower birth weight, multiple birth, and preterm delivery. Pediatrics. 2002 Mar;109(3):399-403. doi: 10.1542/peds.109.3.399.

  PMID: 11875131 BACKGROUND

• Tough S, Tofflemire K, Newburn-Cook C, Fraser-Lee N, Benzies K. Increased risks of pregnancy complications and adverse infant outcomes associated with assisted reproduction. International Congress Series. Research Papers in Fertility and Reproductive Medicine. Proceedings of the 18th World Congress on Fertility and Sterility (IFFS 2004). 2004;1271:376-379.

  BACKGROUND

• Kerstjens JM, de Winter AF, Bocca-Tjeertes IF, Bos AF, Reijneveld SA. Risk of developmental delay increases exponentially as gestational age of preterm infants decreases: a cohort study at age 4 years. Dev Med Child Neurol. 2012 Dec;54(12):1096-101. doi: 10.1111/j.1469-8749.2012.04423.x. Epub 2012 Sep 30.

  PMID: 23020259 BACKGROUND

• Tomashek KM, Shapiro-Mendoza CK, Davidoff MJ, Petrini JR. Differences in mortality between late-preterm and term singleton infants in the United States, 1995-2002. J Pediatr. 2007 Nov;151(5):450-6, 456.e1. doi: 10.1016/j.jpeds.2007.05.002. Epub 2007 Jul 24.

  PMID: 17961684 BACKGROUND

• Sun Y, Hsu P, Vestergaard M, Christensen J, Li J, Olsen J. Gestational age, birth weight, and risk for injuries in childhood. Epidemiology. 2010 Sep;21(5):650-7. doi: 10.1097/EDE.0b013e3181e94253.

  PMID: 20585254 BACKGROUND

• Schonhaut L, Armijo I, Perez M. Gestational age and developmental risk in moderately and late preterm and early term infants. Pediatrics. 2015 Apr;135(4):e835-41. doi: 10.1542/peds.2014-1957. Epub 2015 Mar 2.

  PMID: 25733752 BACKGROUND

• Engle WA; American Academy of Pediatrics Committee on Fetus and Newborn. Age terminology during the perinatal period. Pediatrics. 2004 Nov;114(5):1362-4. doi: 10.1542/peds.2004-1915.

  PMID: 15520122 BACKGROUND

• Harijan P, Boyle EM. Health outcomes in infancy and childhood of moderate and late preterm infants. Semin Fetal Neonatal Med. 2012 Jun;17(3):159-62. doi: 10.1016/j.siny.2012.02.002. Epub 2012 Mar 13.

  PMID: 22417643 BACKGROUND

• Baron IS, Litman FR, Ahronovich MD, Baker R. Late preterm birth: a review of medical and neuropsychological childhood outcomes. Neuropsychol Rev. 2012 Dec;22(4):438-50. doi: 10.1007/s11065-012-9210-5. Epub 2012 Aug 7.

  PMID: 22869055 BACKGROUND

• McGowan JE, Alderdice FA, Holmes VA, Johnston L. Early childhood development of late-preterm infants: a systematic review. Pediatrics. 2011 Jun;127(6):1111-24. doi: 10.1542/peds.2010-2257. Epub 2011 May 29.

  PMID: 21624885 BACKGROUND

• Johnson S, Evans TA, Draper ES, Field DJ, Manktelow BN, Marlow N, Matthews R, Petrou S, Seaton SE, Smith LK, Boyle EM. Neurodevelopmental outcomes following late and moderate prematurity: a population-based cohort study. Arch Dis Child Fetal Neonatal Ed. 2015 Jul;100(4):F301-8. doi: 10.1136/archdischild-2014-307684. Epub 2015 Apr 1.

  PMID: 25834170 BACKGROUND

• Guy A, Seaton SE, Boyle EM, Draper ES, Field DJ, Manktelow BN, Marlow N, Smith LK, Johnson S. Infants born late/moderately preterm are at increased risk for a positive autism screen at 2 years of age. J Pediatr. 2015 Feb;166(2):269-75.e3. doi: 10.1016/j.jpeds.2014.10.053. Epub 2014 Dec 2.

  PMID: 25477165 BACKGROUND

• Kerstjens JM, de Winter AF, Bocca-Tjeertes IF, ten Vergert EM, Reijneveld SA, Bos AF. Developmental delay in moderately preterm-born children at school entry. J Pediatr. 2011 Jul;159(1):92-8. doi: 10.1016/j.jpeds.2010.12.041. Epub 2011 Feb 16.

  PMID: 21324481 BACKGROUND

• Ballantyne M, Benzies KM, McDonald S, Magill-Evans J, Tough S. Risk of developmental delay: Comparison of late preterm and full term Canadian infants at age 12 months. Early Hum Dev. 2016 Oct;101:27-32. doi: 10.1016/j.earlhumdev.2016.04.004. Epub 2016 Jul 9.

  PMID: 27405053 BACKGROUND

• Stene-Larsen K, Brandlistuen RE, Lang AM, Landolt MA, Latal B, Vollrath ME. Communication impairments in early term and late preterm children: a prospective cohort study following children to age 36 months. J Pediatr. 2014 Dec;165(6):1123-8. doi: 10.1016/j.jpeds.2014.08.027. Epub 2014 Sep 23.

  PMID: 25258153 BACKGROUND

• Chan E, Quigley MA. School performance at age 7 years in late preterm and early term birth: a cohort study. Arch Dis Child Fetal Neonatal Ed. 2014 Nov;99(6):F451-7. doi: 10.1136/archdischild-2014-306124. Epub 2014 Jun 25.

  PMID: 24966128 BACKGROUND

• de Jong M, Verhoeven M, van Baar AL. School outcome, cognitive functioning, and behaviour problems in moderate and late preterm children and adults: a review. Semin Fetal Neonatal Med. 2012 Jun;17(3):163-9. doi: 10.1016/j.siny.2012.02.003. Epub 2012 Feb 23.

  PMID: 22364677 BACKGROUND

• van Baar AL, Vermaas J, Knots E, de Kleine MJ, Soons P. Functioning at school age of moderately preterm children born at 32 to 36 weeks' gestational age. Pediatrics. 2009 Jul;124(1):251-7. doi: 10.1542/peds.2008-2315.

  PMID: 19564307 BACKGROUND

• Hornman J, de Winter AF, Kerstjens JM, Bos AF, Reijneveld SA. Emotional and Behavioral Problems of Preterm and Full-Term Children at School Entry. Pediatrics. 2016 May;137(5):e20152255. doi: 10.1542/peds.2015-2255.

  PMID: 27244786 BACKGROUND

• Potijk MR, de Winter AF, Bos AF, Kerstjens JM, Reijneveld SA. Higher rates of behavioural and emotional problems at preschool age in children born moderately preterm. Arch Dis Child. 2012 Feb;97(2):112-7. doi: 10.1136/adc.2011.300131. Epub 2011 Dec 6.

  PMID: 22147746 BACKGROUND

• Potijk MR, de Winter AF, Bos AF, Kerstjens JM, Reijneveld SA. Co-occurrence of developmental and behavioural problems in moderate to late preterm-born children. Arch Dis Child. 2016 Mar;101(3):217-22. doi: 10.1136/archdischild-2015-308958. Epub 2015 Oct 15.

  PMID: 26471109 BACKGROUND

• Blaggan S, Guy A, Boyle EM, Spata E, Manktelow BN, Wolke D, Johnson S. A parent questionnaire for developmental screening in infants born late and moderately preterm. Pediatrics. 2014 Jul;134(1):e55-62. doi: 10.1542/peds.2014-0266.

  PMID: 24982100 BACKGROUND

• Johnson S, Matthews R, Draper ES, Field DJ, Manktelow BN, Marlow N, Smith LK, Boyle EM. Early Emergence of Delayed Social Competence in Infants Born Late and Moderately Preterm. J Dev Behav Pediatr. 2015 Nov-Dec;36(9):690-9. doi: 10.1097/DBP.0000000000000222.

  PMID: 26461097 BACKGROUND

• Dean S. Child Health Strategic Clinical Network meeting: Reporting and analytics. Calgary, AB: Alberta Health Services; 2012.

  BACKGROUND

• Petrou S, Khan K. Economic costs associated with moderate and late preterm birth: primary and secondary evidence. Semin Fetal Neonatal Med. 2012 Jun;17(3):170-8. doi: 10.1016/j.siny.2012.02.001. Epub 2012 Feb 23.

  PMID: 22364679 BACKGROUND

• Briggs-Gowan MJ, Carter AS, Irwin JR, Wachtel K, Cicchetti DV. The Brief Infant-Toddler Social and Emotional Assessment: screening for social-emotional problems and delays in competence. J Pediatr Psychol. 2004 Mar;29(2):143-55. doi: 10.1093/jpepsy/jsh017.

  PMID: 15096535 BACKGROUND

• Kolb B, Whishaw IQ, Teskey GC. An introduction to brain and behavior. New York, NY: Worth Publishers; 2016.

  BACKGROUND

• Shulruf B, Morton S, Goodyear-Smith F, O'Loughlin C, Dixon R. Designing multidisciplinary longitudinal studies of human development: analyzing past research to inform methodology. Eval Health Prof. 2007 Sep;30(3):207-28. doi: 10.1177/0163278707304030.

  PMID: 17693616 BACKGROUND

• Scher MS, Johnson MW, Ludington SM, Loparo K. Physiologic brain dysmaturity in late preterm infants. Pediatr Res. 2011 Nov;70(5):524-8. doi: 10.1203/PDR.0b013e31822f24af.

  PMID: 21796018 BACKGROUND

• Schwichtenberg AJ, Christ S, Abel E, Poehlmann-Tynan JA. Circadian Sleep Patterns in Toddlers Born Preterm: Longitudinal Associations with Developmental and Health Concerns. J Dev Behav Pediatr. 2016 Jun;37(5):358-69. doi: 10.1097/DBP.0000000000000287.

  PMID: 27011003 BACKGROUND

• Booker CL, Harding S, Benzeval M. A systematic review of the effect of retention methods in population-based cohort studies. BMC Public Health. 2011 Apr 19;11:249. doi: 10.1186/1471-2458-11-249.

  PMID: 21504610 BACKGROUND

• Schwarzer, R., & Jerusalem, M. (1995). Generalized Self-Efficacy Scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Casual and control beliefs (pp. 35-37). Windsor, UK: NFER-NELSON.

  BACKGROUND

• Eaton WW, Muntaner C, Smith C, Tien A, Ybarra M. Center for Epidemiologic Studies Depression Scale: Review and revision (CESD and CESD-R). In: Maruish ME, ed. The Use of Psychological Testing for Treatment Planning and Outcomes Assessment. 3rd ed. Mahwah, NJ: Lawrence Erlbaum; 2004:363-377.

  BACKGROUND

• Sadeh A, Mindell JA, Luedtke K, Wiegand B. Sleep and sleep ecology in the first 3 years: a web-based study. J Sleep Res. 2009 Mar;18(1):60-73. doi: 10.1111/j.1365-2869.2008.00699.x. Epub 2008 Oct 16.

  PMID: 19021850 BACKGROUND

• Sadeh A. A brief screening questionnaire for infant sleep problems: validation and findings for an Internet sample. Pediatrics. 2004 Jun;113(6):e570-7. doi: 10.1542/peds.113.6.e570.

  PMID: 15173539 BACKGROUND

• Sadeh A, Mindell J, Rivera L. "My child has a sleep problem": a cross-cultural comparison of parental definitions. Sleep Med. 2011 May;12(5):478-82. doi: 10.1016/j.sleep.2010.10.008. Epub 2011 Apr 7.

  PMID: 21478050 BACKGROUND

• Radloff, L. S. (1977). The CES-D scale: A self report depression scale for research in the general population. Applied Psychological Measurements, 1, 385-401.

  BACKGROUND

• Teng A, Bartle A, Sadeh A, Mindell J. Infant and toddler sleep in Australia and New Zealand. J Paediatr Child Health. 2012 Mar;48(3):268-73. doi: 10.1111/j.1440-1754.2011.02251.x. Epub 2011 Nov 22.

  PMID: 22107168 BACKGROUND

• Mindell JA, Du Mond CE, Sadeh A, Telofski LS, Kulkarni N, Gunn E. Efficacy of an internet-based intervention for infant and toddler sleep disturbances. Sleep. 2011 Apr 1;34(4):451-8. doi: 10.1093/sleep/34.4.451.

  PMID: 21461323 BACKGROUND

• Caro J, Erslev AJ. Uremic inhibitors of erythropoiesis. Semin Nephrol. 1985 Jun;5(2):128-32. No abstract available.

  PMID: 3879951 BACKGROUND

• Spielberger CD, Gorsuch RL, Lushene RE. Test manual for the State-Trait Anxiety Inventory. Palo Alto, CA: Consulting Psychologists Press; 1970.

  BACKGROUND

• Abidin RR. Parenting Stress Index - Fourth Edition - Short Form. Lutz, FL: Psychological Assessment Resources; 2012.

  BACKGROUND

• Eaton WW, Smith C, Ybarra M, Muntaner C, Tien A. Center for Epidemiologic Studies Depression Scale: Review and revision (CESD and CESD-R). In: Maruish ME, ed. The use of psychological testing for treatment planning and outcomes assessment: Volume 3 - Instruments for adults. Mahwah, NJ: Lawrence Erlbaum Associates; 2004:363-377.

  BACKGROUND

• Schwarzer R, Jerusalem M. Generalized Self-Efficacy Scale. In: Weinman J, Wright S, Johnston M, eds. Measures in health psychology: A user's portfolio. Causal and control beliefs. Windsor, UK: NEFR-NELSON; 1995:35-37.

  BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Abhay Lodha, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Khalid Aziz, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Vibhuti Shah, MD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor; Associate Dean, Research

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: November 9, 2017
• Study Start: September 27, 2017
• Primary Completion: March 26, 2020
• Study Completion: March 26, 2020
• Last Updated: December 11, 2024

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)