Multidimensional assessment of infant, parent and staff outcomes during a family centered care enhancement project in a tertiary neonatal intensive care unit: study protocol of a longitudinal cohort study.
Depression in mothers and fathers
Discharge
Family centred care
Family integrated care
NICU
PDSA
Preterm infants
Staff satisfaction
Journal
BMC pediatrics
ISSN: 1471-2431
Titre abrégé: BMC Pediatr
Pays: England
ID NLM: 100967804
Informations de publication
Date de publication:
07 07 2023
07 07 2023
Historique:
received:
20
04
2022
accepted:
28
06
2023
medline:
10
7
2023
pubmed:
8
7
2023
entrez:
7
7
2023
Statut:
epublish
Résumé
The therapeutic advances and progress in the care for preterm infants have enabled the regular survival of very immature infants. However, the high burden of lifelong sequelae following premature delivery constitutes an ongoing challenge. Regardless of premature delivery, parental mental health and a healthy parent-child relationship were identified as essential prerogatives for normal infant development. Family centered care (FCC) supports preterm infants and their families by respecting the particular developmental, social and emotional needs in the Neonatal Intensive Care Unit. Due to the large variations in concepts and goals of different FCC initiatives, scientific data on the benefits of FCC for the infant and family outcome are sparse and its effects on the clinical team need to be elaborated. This prospective single centre longitudinal cohort study enrols preterm infants ≤ 32 + 0 weeks of gestation and/or birthweight ≤ 1500 g and their parents at the neonatal department of the Giessen University Hospital, Giessen, Germany. Following a baseline period, the rollout of additional FCC elements is executed following a stepwise 6-months approach that covers the NICU environment, staff training, parental education and psychosocial support for parents. Recruitment is scheduled over a 5.5. year period from October 2020 to March 2026. The primary outcome is corrected gestational age at discharge. Secondary infant outcomes include neonatal morbidities, growth, and psychomotor development up to 24 months. Parental outcome measures are directed towards parental skills and satisfaction, parent-infant-interaction and mental health. Staff issues are elaborated with particular focus on the item workplace satisfaction. Quality improvement steps are monitored using the Plan- Do- Study- Act cycle method and outcome measures cover the infant, the parents and the medical team. The parallel data collection enables to study the interrelation between these three important areas of research. Sample size calculation was based on the primary outcome. It is scientifically impossible to allocate improvements in outcome measures to individual enhancement steps of FCC that constitutes a continuous change in NICU culture and attitudes covering diverse areas of change. Therefore, our trial is designed to allocate childhood, parental and staff outcome measures during the stepwise changes introduced by a FCC intervention program. Clinicaltrials.gov, trial registration number NCT05286983, date of registration 03/18/2022, retrospectively registered, http://clinicaltrials.gov .
Sections du résumé
BACKGROUND
The therapeutic advances and progress in the care for preterm infants have enabled the regular survival of very immature infants. However, the high burden of lifelong sequelae following premature delivery constitutes an ongoing challenge. Regardless of premature delivery, parental mental health and a healthy parent-child relationship were identified as essential prerogatives for normal infant development. Family centered care (FCC) supports preterm infants and their families by respecting the particular developmental, social and emotional needs in the Neonatal Intensive Care Unit. Due to the large variations in concepts and goals of different FCC initiatives, scientific data on the benefits of FCC for the infant and family outcome are sparse and its effects on the clinical team need to be elaborated.
METHODS
This prospective single centre longitudinal cohort study enrols preterm infants ≤ 32 + 0 weeks of gestation and/or birthweight ≤ 1500 g and their parents at the neonatal department of the Giessen University Hospital, Giessen, Germany. Following a baseline period, the rollout of additional FCC elements is executed following a stepwise 6-months approach that covers the NICU environment, staff training, parental education and psychosocial support for parents. Recruitment is scheduled over a 5.5. year period from October 2020 to March 2026. The primary outcome is corrected gestational age at discharge. Secondary infant outcomes include neonatal morbidities, growth, and psychomotor development up to 24 months. Parental outcome measures are directed towards parental skills and satisfaction, parent-infant-interaction and mental health. Staff issues are elaborated with particular focus on the item workplace satisfaction. Quality improvement steps are monitored using the Plan- Do- Study- Act cycle method and outcome measures cover the infant, the parents and the medical team. The parallel data collection enables to study the interrelation between these three important areas of research. Sample size calculation was based on the primary outcome.
DISCUSSION
It is scientifically impossible to allocate improvements in outcome measures to individual enhancement steps of FCC that constitutes a continuous change in NICU culture and attitudes covering diverse areas of change. Therefore, our trial is designed to allocate childhood, parental and staff outcome measures during the stepwise changes introduced by a FCC intervention program.
TRIAL REGISTRATION
Clinicaltrials.gov, trial registration number NCT05286983, date of registration 03/18/2022, retrospectively registered, http://clinicaltrials.gov .
Identifiants
pubmed: 37420180
doi: 10.1186/s12887-023-04165-0
pii: 10.1186/s12887-023-04165-0
pmc: PMC10326953
doi:
Banques de données
ClinicalTrials.gov
['NCT05286983']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
344Informations de copyright
© 2023. The Author(s).
Références
J Perinatol. 2003 Sep;23(6):451-6
pubmed: 13679930
PLoS One. 2021 Jun 9;16(6):e0252074
pubmed: 34106929
Qual Saf Health Care. 2003 Dec;12(6):458-64
pubmed: 14645763
BMJ Qual Saf. 2014 Apr;23(4):290-8
pubmed: 24025320
Pediatrics. 2021 Aug;148(2):
pubmed: 34341101
J Perinatol. 2020 Mar;40(3):530-539
pubmed: 31712659
Arch Dis Child Fetal Neonatal Ed. 2020 Mar;105(2):190-195
pubmed: 31248963
Pediatr Res. 2020 Aug;88(2):257-264
pubmed: 31896122
Pediatrics. 2003 Apr;111(4 Pt 2):e437-49
pubmed: 12671164
BMC Health Serv Res. 2017 Jun 19;17(1):411
pubmed: 28629348
Acta Paediatr. 2017 Jun;106(6):878-888
pubmed: 28235152
Semin Fetal Neonatal Med. 2020 Jun;25(3):101119
pubmed: 32446767
Birth Defects Res. 2019 Sep 1;111(15):1044-1059
pubmed: 31115181
Arch Dis Child Fetal Neonatal Ed. 2022 Jan;107(1):76-81
pubmed: 34145042
BMJ Qual Saf. 2016 Dec;25(12):986-992
pubmed: 26369893
Arch Dis Child Fetal Neonatal Ed. 2018 Jan;103(1):F43-F48
pubmed: 28659361
Curr Opin Pediatr. 2017 Apr;29(2):129-134
pubmed: 28059902
J Psychosom Obstet Gynaecol. 2021 Jun;42(2):162-167
pubmed: 32897157
Pediatrics. 2003 Apr;111(4 Pt 2):e450-60
pubmed: 12671165
JAMA Netw Open. 2022 Jan 4;5(1):e2144720
pubmed: 35072721
Pediatrics. 2012 Feb;129(2):394-404
pubmed: 22291118
Int J Health Care Qual Assur. 2010;23(3):312-27
pubmed: 20535903
J Pediatr. 1978 Apr;92(4):529-34
pubmed: 305471
CMAJ. 2020 Jan 27;192(4):E81-E91
pubmed: 31988152
Pediatrics. 1993 Nov;92(5):643-50
pubmed: 8414850
Paediatr Child Health. 2015 Jan-Feb;20(1):e1-9
pubmed: 25722645
Early Hum Dev. 2012 Jan;88(1):45-9
pubmed: 21782361
Lancet Child Adolesc Health. 2018 Apr;2(4):245-254
pubmed: 30169298
Value Health. 2005 Mar-Apr;8(2):94-104
pubmed: 15804318
Scand J Work Environ Health. 2005 Dec;31(6):438-49
pubmed: 16425585
Semin Perinatol. 2011 Feb;35(1):20-8
pubmed: 21255703
PLoS One. 2016 Mar 29;11(3):e0151091
pubmed: 27022953
Pediatrics. 2018 Jan;141(1):
pubmed: 29255083
Aust Crit Care. 2019 Jan;32(1):63-75
pubmed: 30554939
JAMA. 2003 Apr 16;289(15):1969-75
pubmed: 12697800
Early Hum Dev. 2019 Mar;130:10-16
pubmed: 30639968
J Perinat Neonatal Nurs. 2011 Oct-Dec;25(4):342-8
pubmed: 22071618
BMC Health Serv Res. 2019 Oct 4;19(1):683
pubmed: 31585540
Nurs Adm Q. 2009 Apr-Jun;33(2):116-24
pubmed: 19305308
Pediatrics. 2006 Nov;118 Suppl 2:S95-107
pubmed: 17079629
Clin Perinatol. 2017 Sep;44(3):627-644
pubmed: 28802343
Ann Surg. 1978 Jan;187(1):1-7
pubmed: 413500
J Perinatol. 2018 Jul;38(7):929-935
pubmed: 29795322
Birth. 2003 Mar;30(1):31-5
pubmed: 12581037
Pediatrics. 2019 Jun;143(6):
pubmed: 31053622
Front Pediatr. 2020 Aug 25;8:505
pubmed: 32984217
JAMA Pediatr. 2016 Oct 01;170(10):954-963
pubmed: 27479919
J Paediatr Child Health. 2020 Apr;56(4):512-520
pubmed: 31774595