NCT04883866

Brief Summary

It was observed that premature babies had the risk of insufficient milk intake and a lower rate of breastfeeding compared to term babies. Various problems may occur at home, especially after breastfeeding training in the hospital. After discharge, support and counseling should be provided to eliminate problems that may stop breastfeeding or to prevent events that may prevent breastfeeding. The aim of this study is to examine the effect of "Telephone Breastfeeding Support" given to mothers of premature babies discharged from the neonatal intensive care unit on breastfeeding results.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

May 7, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

May 7, 2021

Last Update Submit

July 20, 2021

Conditions

Keywords

Telephone based support,

Outcome Measures

Primary Outcomes (3)

  • Breastfeeding Self-Efficacy Scale (short form)

    The scale, which is valid and reliable in our country by Aluş Tokat, Okun and Dennis (2010), consists of 14 items and is a Likert type scale rated between 1 and 5. The minimum score that can be retrieved from the scale is 14 and the maximum is 70. As the score rises, high breastfeeding is an indicator of self-sufficiency.

    0-6 months (During discharge routine procedures and when the baby is six months old)

  • Infant Feeding Attitude Scale

    The scale was developed to evaluate women's attitudes towards breastfeeding and to predict breastfeeding duration as well as the choice of baby feeding method. The scale consists of 5-point Likert type and 17 items. The total attitude score ranges from 17 (showing a positive attitude to bottle feeding) to 85 (reflecting a positive attitude towards breastfeeding). The higher the score on the scale, the higher it indicates the higher breastfeeding attitude.

    0-6 months (During discharge routine procedures and when the baby is six months old)

  • 3. Breastfeeding Time Evaluation Form Breastfeeding Time Evaluation Form Breastfeeding Time Evaluation Form

    Prepared by researcher to find out breastfeeding status when babies are 6 months old.

    When the baby is six months old

Study Arms (2)

Intervention Group

EXPERIMENTAL

Sending breastfeeding guidelines for premature babies to phones after the discharge procedure is completed.and implementing a "Telephone Breastfeeding Support Program".

Behavioral: Telephone Breastfeeding Support ProgramBehavioral: Sending a breastfeeding guide for premature babies to the phone of mothers in addition to the routine discharge procedure

Control Group

EXPERIMENTAL

Sending breastfeeding guidelines for premature babies to phones after the discharge procedure is completed.

Behavioral: Sending a breastfeeding guide for premature babies to the phone of mothers in addition to the routine discharge procedure

Interventions

On the 3rd day after discharge, a reminder messages will be sent to the mothers in the inter vention group. Throughout the program, 21 reminder messages will be sent to mothers in the first month after discharge to support the mother and encourage breast milk via a messaging application (whatsapp, bip, telegram, etc.). In addition, a total of seven phone calls, once a week in the first month after discharge and once a month in the eighth, twelfth and sixteenth weeks, will be made to check personalized information about individual breastfeeding questions of mothers.

Intervention Group

In addition to the routine discharge procedure, a breastfeeding guide for premature babies will be sent to the mothers' phone.

Control GroupIntervention Group

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsChild, Adult, Older Adult
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Whose baby was born between 34 weeks + 0 days and 36 weeks + 6 days (late preterms),
  • Does not have severe congenital anomalies in her baby (according to hospital records),
  • Breastfeeding her baby,
  • Reading and writing,
  • Can speak and understand Turkish,
  • Mothers who agreed to participate in the study,
  • Mothers having a smartphone.

You may not qualify if:

  • Mothers with previous experience of breastfeeding a premature baby,
  • Plural baby,
  • Mother's breastfeeding disability (according to hospital records).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, 07000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Premature BirthBreast Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFeeding BehaviorBehavior

Study Officials

  • Arzu Akcan, PhD

    +905334436659

    STUDY DIRECTOR

Central Study Contacts

Ezgi Boz, Postgraduate

CONTACT

Arzu Akcan, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
At the time of discharge, the participants will not know that they are in the intervention and control group. Participants will be blinded. In the evaluation of the data, the groups will not be coded as intervention and control groups, they will be coded as group A and group B, and their analysis will be evaluated and reported by an independent statistician. In addition, the statistician will be blind.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a pretest-posttest designed randomized controlled trial using the stratified block randomization method.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 7, 2021

First Posted

May 12, 2021

Study Start

June 1, 2021

Primary Completion

December 1, 2021

Study Completion

July 1, 2022

Last Updated

July 22, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations