Ignite Creation Date:
2024-05-06 @ 4:06 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02452580
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2015-02-03
Brief Title:
The Norwegian Family Centered Care Study
Sponsor:
Vestre Viken Hospital Trust
Organization:
Vestre Viken Hospital Trust
Study Overview
Official Title:
Impact of Family Centered Care on Preterm Infants and Their Parents
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
Active not recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study evaluates possible effects of two different NICU designs by comparing traditional and Family Centered Care in terms of infant nutrition health and growth and coping by family
Detailed Description:
Two Norwegian neonatal intensive care units NICU participate in this study Haukeland University Hospital HUH and Vestre Viken Hospital Trust VVHT
The NICU at HUH was built around 1980 as a traditional unit It is crowded has no single rooms or access to rooming in with the parents The NICU at VVHT opened in April 2012 and it is unique in its kind both in a Norwegian and European context A shift from traditional NICU to a FCC unit involves both physical structural changes and involves the entire interdisciplinary team around the individual families The main difference is firstly the involvement of parents and their right to be present together with infant and secondly the establishment of parents as the responsible caregivers for the infant even when the infant is hospitalized This comprises so-called minimal handling the number of medical procedures are reduced to the very strictest necessities and restructuring the common nursing interventions The infant is given Kangaroo Mother Care KMC skin-to-skin rather than being in an incubator
The first question raised and discussed is whether the FCC - with parents present in Single Room Care 24 hours and performing KMC - will affect the preterm infants growth and attainment of breastfeeding The second question raised and discussed is whether the surroundings in FCC-unit - with parents present - will affect parents reports on parental health in relation to psychological stress anxiety and depression also in a longitudinal perspective The purpose of the study is to evaluate possible effects of these two different NICU designs the traditional open bay unit with limited space and no possibilities for parents to continuously stay with their infant and the novel model physically and culturally optimized for parent-infant interaction 24 hours a day 7 days a week from birth to discharge Although an intriguing novel asset to neonatal intensive care the effects of FCC on the childs and familys somatic and mental health on NICU staff and cost of care have not been scientifically scrutinized There is so far lack of valid knowledge about effect of FCC in a single room unit with parents present to the extent we can offer in Nordic countries
A randomized controlled study RCT in a single unit would be ethically and methodologically impossible to conduct eg since it will be impossible to avoid contamination between groups and a Cochrane review argued that comparison between different units would be the most valid method This recommended approach will be followed in the present study and the challenge is to minimize factors that may act as confounders To minimize confounding the following details on design will be adhered to
Recruitment of comparable infant - parent dyads
Strict definitions of independent and outcome variables egnutrition
Prospective registration Parental presence and duration of KMC infant nutrition growth investigations and occurrence of morbidity will be prospectively and similarly registered during the hospital stay under supervision by a designated research nurse
All data on growth will be transferred to z-scores based on standardized growth charts for Norwegian infants for pre and post term growth Relevant statistical methods for comparisons will be applied and statistical methods will be chosen in cooperation with a biostatistician
The main outcome is weight at 34 weeks and 40 weeks post menstrual age PMA basically calculated as z-score increments between 34 and 40 weeks Judged from a pilot study it is actually sufficient with only ten children in each group to detect a difference in weight of 100 gram 34 Gestational age GA weeks with a power of 80 at a significance level of less than 005 However due to the other variables and analyzes among other mixed model it is appropriate with about 100 infants 50 in each group An important secondary outcome is length of stay in terms of PMA at discharge From data at HUH a difference in PMA at discharge of 5 days which is considered clinically relevant will require 42 infants in each leg calculated from a standard deviation of 13 days power of 80 and p 005 From these data one year recruitment will be sufficient in that in our experience more than 90 will agree to participate We will consider expanding inclusion to 1 ½ years 75 infants in each branch to allow for power to assess effects of other explanatory variables
Parents who agree to participate are registered in a database containing name personal identification number a code number which corresponds to other files information relating to the date the questionnaires are sent or received and whether or not reminders have been sent No other information is stored in this database The data will be stored at the respective Research servers at VVHT and HUH according to the requirements of the hospitals and the Regional Committees for Medical and Health Research Ethics de-identified study file and a file with a key to the study file Transfer of data from HUH to VVHF will be performed as encrypted files according to requirements All participants will be asked to sign an informed consent form at the enrolment in the study
The NICU at HUH was built around 1980 as a traditional unit It is crowded has no single rooms or access to rooming in with the parents The NICU at VVHT opened in April 2012 and it is unique in its kind both in a Norwegian and European context A shift from traditional NICU to a FCC unit involves both physical structural changes and involves the entire interdisciplinary team around the individual families The main difference is firstly the involvement of parents and their right to be present together with infant and secondly the establishment of parents as the responsible caregivers for the infant even when the infant is hospitalized This comprises so-called minimal handling the number of medical procedures are reduced to the very strictest necessities and restructuring the common nursing interventions The infant is given Kangaroo Mother Care KMC skin-to-skin rather than being in an incubator
The first question raised and discussed is whether the FCC - with parents present in Single Room Care 24 hours and performing KMC - will affect the preterm infants growth and attainment of breastfeeding The second question raised and discussed is whether the surroundings in FCC-unit - with parents present - will affect parents reports on parental health in relation to psychological stress anxiety and depression also in a longitudinal perspective The purpose of the study is to evaluate possible effects of these two different NICU designs the traditional open bay unit with limited space and no possibilities for parents to continuously stay with their infant and the novel model physically and culturally optimized for parent-infant interaction 24 hours a day 7 days a week from birth to discharge Although an intriguing novel asset to neonatal intensive care the effects of FCC on the childs and familys somatic and mental health on NICU staff and cost of care have not been scientifically scrutinized There is so far lack of valid knowledge about effect of FCC in a single room unit with parents present to the extent we can offer in Nordic countries
A randomized controlled study RCT in a single unit would be ethically and methodologically impossible to conduct eg since it will be impossible to avoid contamination between groups and a Cochrane review argued that comparison between different units would be the most valid method This recommended approach will be followed in the present study and the challenge is to minimize factors that may act as confounders To minimize confounding the following details on design will be adhered to
Recruitment of comparable infant - parent dyads
Strict definitions of independent and outcome variables egnutrition
Prospective registration Parental presence and duration of KMC infant nutrition growth investigations and occurrence of morbidity will be prospectively and similarly registered during the hospital stay under supervision by a designated research nurse
All data on growth will be transferred to z-scores based on standardized growth charts for Norwegian infants for pre and post term growth Relevant statistical methods for comparisons will be applied and statistical methods will be chosen in cooperation with a biostatistician
The main outcome is weight at 34 weeks and 40 weeks post menstrual age PMA basically calculated as z-score increments between 34 and 40 weeks Judged from a pilot study it is actually sufficient with only ten children in each group to detect a difference in weight of 100 gram 34 Gestational age GA weeks with a power of 80 at a significance level of less than 005 However due to the other variables and analyzes among other mixed model it is appropriate with about 100 infants 50 in each group An important secondary outcome is length of stay in terms of PMA at discharge From data at HUH a difference in PMA at discharge of 5 days which is considered clinically relevant will require 42 infants in each leg calculated from a standard deviation of 13 days power of 80 and p 005 From these data one year recruitment will be sufficient in that in our experience more than 90 will agree to participate We will consider expanding inclusion to 1 ½ years 75 infants in each branch to allow for power to assess effects of other explanatory variables
Parents who agree to participate are registered in a database containing name personal identification number a code number which corresponds to other files information relating to the date the questionnaires are sent or received and whether or not reminders have been sent No other information is stored in this database The data will be stored at the respective Research servers at VVHT and HUH according to the requirements of the hospitals and the Regional Committees for Medical and Health Research Ethics de-identified study file and a file with a key to the study file Transfer of data from HUH to VVHF will be performed as encrypted files according to requirements All participants will be asked to sign an informed consent form at the enrolment in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None