The Norwegian Family Centered Care Study
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|ClinicalTrials.gov Identifier: NCT02452580|
Recruitment Status : Active, not recruiting
First Posted : May 22, 2015
Last Update Posted : May 6, 2021
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|Condition or disease||Intervention/treatment|
|Premature Birth of Newborn||Other: Family Centered Care|
|Study Type :||Observational|
|Actual Enrollment :||77 participants|
|Official Title:||Impact of Family Centered Care on Preterm Infants and Their Parents|
|Actual Study Start Date :||September 1, 2013|
|Actual Primary Completion Date :||February 28, 2016|
|Estimated Study Completion Date :||June 1, 2023|
Family Centered Care Unit
Cohort of premature infants and their families receiving Family Centered Care hospitalized at VVHF
Other: Family Centered Care
Neonatal intensive care toward premature infants and their parents in a unit physically and culturally optimized for parent-infant interaction 24 hours a day 7 days a week from birth to discharge.
Open-bay Care Unit
Cohort of premature infants and their families receiving and traditional open-bay care hospitalized at HUH
- Change in growth (composite) [ Time Frame: from birth to 4 months corrected age ]Observations of weight, body length, upper arm and head circumference
- Occurrence of morbidity [ Time Frame: Participants will be followed for duration of hospital stay, an expected average of 38 days ]Selected from Medical records
- Oxygen therapy [ Time Frame: Participants will be followed for duration of hospital stay, an expected average of 38 days ]Selected from Medical records
- Volume of mother's milk [ Time Frame: From birth to 34 PMA ]Mothers measure herself
- Nutrition [ Time Frame: From birth to 34 po 4 months corrected age ]Type of nutrition (parenteral, mother's milk, banked breast milk), mode of increment until full enteral feeds, type and timing of fortification of breast-milk, volume of milk per day based on body weight, rate of breastfeeding at discharge, term date and 4 months corrected age and postmenstrual age (PMA) when accomplishing breast-feeding
- Parental presence [ Time Frame: From birth to 34 postmenstrual age (PMA) ]Diary field out by the parents
- Skin to skin care [ Time Frame: From birth to 34 postmenstrual age (PMA) ]Diary field out by the parents
- Mothers' confidence in breastfeeding [ Time Frame: At discharge, an expected average 38 days after birth ]The questionnaire "The Breastfeeding Self-Efficacy Scale-Short Form" (BSES-SF)
- Parent stress [ Time Frame: From birth to 4 months corrected age ]The questionnaire "The Parent stress scale: NICU (PSS:NICU)" and The questionnaire The Parenting Stress Index (PSI)
- Parent depression [ Time Frame: From birth to 4 months corrected age ]The questionnaire "The Edinburgh Postnatal Depression Scale (EPDS)"
- Parent anxiety [ Time Frame: From birth to 4 months corrected age ]The questionnaire "The STAI Short Form Y (STAI)"
- Parents report on interacting with the infant [ Time Frame: From birth to 4 months corrected age ]The questionnaire "Maternal Postnatal Attachment Scale (MPAS)"
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|Ages Eligible for Study:||28 Weeks to 32 Weeks (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- All eligible infants (gestational age 28-32 weeks) at VVHT and HUH.
- If infant suffers from congenital malformations or chronic disease, i.e intraventricular hemorrhage grade III or IV, undergo surgical treatment for Necrotizing enterocolitis or if the birth weight is less than 800 grams.
- Furthermore, we will exclude families from participation if the mother or father suffers from serious mental illness
- If they don't understand Norwegian (oral and written)
- If the mother was taking illicit drugs or was treated with methadone or Subutex during pregnancy or in cases of severe social challenges in the family, e.i. infant being submitted to Child Protective Services immediately after birth.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02452580
|Vestre Viken Hospital Trust|
|Drammen, Buskerud, Norway, 3004|
|Principal Investigator:||Atle Moen, Phd||Vestre viken hospital trust, Norway|
|Principal Investigator:||Trond Markestad, Prof||The Universty of Bergen, Norway|
|Principal Investigator:||Renèe Flacking, Ass prof||The univiversity of Dalarne, Sweden|
|Responsible Party:||Vestre Viken Hospital Trust|
|Other Study ID Numbers:||
|First Posted:||May 22, 2015 Key Record Dates|
|Last Update Posted:||May 6, 2021|
|Last Verified:||April 2021|
Kangaroo Mother Care
Neonatal Intensive Care Units
Obstetric Labor, Premature
Obstetric Labor Complications