Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 17 for:    family centered care | Norway
Previous Study | Return to List | Next Study

The Norwegian Family Centered Care Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02452580
Recruitment Status : Active, not recruiting
First Posted : May 22, 2015
Last Update Posted : May 6, 2021
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Vestre Viken Hospital Trust

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.

Condition or disease Intervention/treatment
Premature Birth of Newborn Other: Family Centered Care

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Change in growth (composite) [ Time Frame: from birth to 4 months corrected age ]
    Observations of weight, body length, upper arm and head circumference


Secondary Outcome Measures :
  1. Occurrence of morbidity [ Time Frame: Participants will be followed for duration of hospital stay, an expected average of 38 days ]
    Selected from Medical records

  2. Oxygen therapy [ Time Frame: Participants will be followed for duration of hospital stay, an expected average of 38 days ]
    Selected from Medical records

  3. Volume of mother's milk [ Time Frame: From birth to 34 PMA ]
    Mothers measure herself

  4. 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

  5. Parental presence [ Time Frame: From birth to 34 postmenstrual age (PMA) ]
    Diary field out by the parents

  6. Skin to skin care [ Time Frame: From birth to 34 postmenstrual age (PMA) ]
    Diary field out by the parents

  7. 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)

  8. 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)

  9. Parent depression [ Time Frame: From birth to 4 months corrected age ]
    The questionnaire "The Edinburgh Postnatal Depression Scale (EPDS)"

  10. Parent anxiety [ Time Frame: From birth to 4 months corrected age ]
    The questionnaire "The STAI Short Form Y (STAI)"

  11. Parents report on interacting with the infant [ Time Frame: From birth to 4 months corrected age ]
    The questionnaire "Maternal Postnatal Attachment Scale (MPAS)"



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   28 Weeks to 32 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All infants (gestational age 28-32 weeks) and their parents hopitalized at VVHT and HUH.The recruited parent-infant dyads will thus be population based, i.e. representing the county of Buskerud and Hordaland. Patients will be recruited consecutively at admission to the NICU and included after written informed consent by both parents.
Criteria

Inclusion Criteria:

  • All eligible infants (gestational age 28-32 weeks) at VVHT and HUH.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
Norway
Vestre Viken Hospital Trust
Drammen, Buskerud, Norway, 3004
Sponsors and Collaborators
Vestre Viken Hospital Trust
Haukeland University Hospital
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Vestre Viken Hospital Trust
ClinicalTrials.gov Identifier: NCT02452580    
Other Study ID Numbers: Vestreviken -1403001
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: April 2021
Keywords provided by Vestre Viken Hospital Trust:
Kangaroo Mother Care
Neonatal Intensive Care Units
Postnatal growth
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications