The Norwegian Family Centered Care Study

NCT02452580 | Active Not Recruiting DMC

• 1 other identifier: Vestreviken -1403001
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth of Newborn

Keywords

Kangaroo Mother Care; Neonatal Intensive Care Units; Postnatal growth

Outcome Measures

Primary Outcomes (1)

• Change in growth (composite)

  Observations of weight, body length, upper arm and head circumference

  from birth to 4 months corrected age

Secondary Outcomes (11)

• Occurrence of morbidity

  Participants will be followed for duration of hospital stay, an expected average of 38 days

• Oxygen therapy

  Participants will be followed for duration of hospital stay, an expected average of 38 days

• Volume of mother's milk

  From birth to 34 PMA

• Nutrition

  From birth to 34 po 4 months corrected age

• Parental presence

  From birth to 34 postmenstrual age (PMA)

Study Arms (2)

Family Centered Care Unit

Cohort of premature infants and their families receiving Family Centered Care hospitalized at VVHF

Other: Family Centered Care

Open-bay Care Unit

Cohort of premature infants and their families receiving and traditional open-bay care hospitalized at HUH

Interventions

Family Centered Care OTHER

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.

Family Centered Care Unit

Eligibility Criteria

• Age: 28 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead
• Haukeland University Hospital: collaborator

Study Sites (1)

Vestre Viken Hospital Trust

Drammen, Buskerud, 3004, Norway

Location

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

• Bente S Tandberg, Phd

  Vestre viken hospital trust, Norway

  PRINCIPAL INVESTIGATOR

• Renèe Flacking, Prof

  The univiversity of Dalarne, Sweden

  STUDY CHAIR

• Atle Moen, Phd

  Oslo University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: May 22, 2015
• Study Start: September 1, 2013
• Primary Completion: February 28, 2016
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

NO (1)