NCT03070041

Brief Summary

The impact of Baby-friendly Hospital Initiative (BFHI) to breastfeeding, breastfeeding counselling and breastfeeding attitudes will be examined in Satakunta Central Hospital, Finland. The baseline measurement will be conducted before the implementation of BFHI in 2017 and second measurement will be conducted in 2019 after the certification process. Both staff members and breastfeeding mothers will be recruited in the study. The main outcomes are the duration of breastfeeding and breastfeeding attitudes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
425

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
29 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

2.9 years

First QC Date

February 28, 2017

Last Update Submit

November 5, 2020

Conditions

Breastfeeding

Outcome Measures

Primary Outcomes (1)

  • Duration of breastfeeding

    Duration of breastfeeding will be asked from the mother

    Six months

Secondary Outcomes (2)

  • Breastfeeding attitude of the staff (questionnaire)

    Two years

  • Breastfeeding attitude of the mothers (questionnaire)

    Four months

Study Arms (1)

Mothers and staff members

EXPERIMENTAL

The mothers who will give birth at the study hospital and all the staff members taking care about mothers and/or infants

Other: Baby-friendly Hospital Initiative

Interventions

Baby-friendly Hospital InitiativeOTHER

The intervention is Baby-friendly Hospital Initiative as described by WHO and UNICEF. The ten steps to successful breastfeeding will be implemented in the hospital.

Mothers and staff members

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Staff: All staff members taking care of mothers and/or infants in the hospital.
  • Mothers: Mothers who have given birth in the study hospital during the data collection period.

You may not qualify if:

  • Mothers:
  • who have given birth outside the hospital,
  • whose infant's condition is critical,
  • whose infants are transferred to another unit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Satasairaala Central Hospital

Pori, Finland

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post doc researcher

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 3, 2017

Study Start

April 1, 2017

Primary Completion

February 28, 2020

Study Completion

February 28, 2020

Last Updated

November 6, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)