NCT02580786

Brief Summary

This study examines if the internet-based peer support has an effect on the breastfeeding attitude or the duration of breastfeeding in preterm infants and their mothers compared with mothers with routine care. The factors associated with the initiation of breastfeeding in the neonatal intensive care unit will be determined. In addition, the perceptions of the mothers of preterm infants about their needs and problems when breastfeeding their preterm infants are described.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

June 1, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
Last Updated

October 22, 2015

Status Verified

October 1, 2015

Enrollment Period

3.9 years

First QC Date

October 15, 2015

Last Update Submit

October 21, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • Duration of breastfeeding

    12 months

  • Breastfeeding attitude with Iowa Infant Feeding Attitude Scale

    Iowa Infant Feeding Attitude Scale (IIFAS) is used to measure breastfeeding attitude

    6 months

Secondary Outcomes (2)

  • Initiation of breastfeeding (postnatal age of the preterm infant)

    2 months

  • Duration of expressing milk

    12 months

Study Arms (2)

Breastfeeding peer support

EXPERIMENTAL

Internet-based breastfeeding peer-support group in social media (Facebook). The mothers are allowed to use the group based on their individual needs from the recruitment to the first birthday of their child. Peer support is provided by three voluntary mothers. The mothers can discuss breastfeeding-related issues and ask questions. A midwife will moderate the group.

Behavioral: Breastfeeding peer support

Routine breastfeeding support

NO INTERVENTION

Routine breastfeeding support provided in the hospital and in the maternal and child health clinics

Interventions

Breastfeeding peer support

Eligibility Criteria

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

You may qualify if:

  • Mothers giving birth before full 35 gestational weeks in a study hospital

You may not qualify if:

  • The mother not able to speak Finnish
  • The infant's condition is critical (based on the paediatrician),
  • The mother has a syndrome or illness preventing breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast FeedingPremature Birth

Condition Hierarchy (Ancestors)

Feeding BehaviorBehaviorObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MNSc, Doctoral candidate

Study Record Dates

First Submitted

October 15, 2015

First Posted

October 20, 2015

Study Start

June 1, 2011

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

October 22, 2015

Record last verified: 2015-10