search
Back to results

Phone Breastfeeding Support for Premature Babies

Primary Purpose

Preterm Birth, Breastfeeding

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telephone Breastfeeding Support Program
Sending a breastfeeding guide for premature babies to the phone of mothers in addition to the routine discharge procedure
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring Telephone based support,

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • Akdeniz UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 7, 2021
Last Updated
July 20, 2021
Sponsor
Akdeniz University
search

1. Study Identification

Unique Protocol Identification Number
NCT04883866
Brief Title
Phone Breastfeeding Support for Premature Babies
Official Title
Impact of Telephone Breastfeeding Support on Breastfeeding Outcomes for Mothers With Premature Babies: Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
The study was planned as a randomized, parallel two-group, controlled experimental design. This research will be conducted between June 2021 and June 2022 with premature baby mothers. The sample of the study will be mothers (n = 62) of premature babies discharged from Antalya Training and Research Hospital Neonatal Intensive Care Unit. The discharge routine procedures of all mothers participating in the study will be completed and a breastfeeding guide prepared for premature babies will be sent to the phone. On the 3rd day after discharge, a reminder message will be sent to support the mother in the intervention group (n = 31) and to encourage breast milk. Throughout the program, 21 messages will be sent to the mothers in the first month after discharge, via the messaging application (whatsapp, bip, telegram, etc.) In addition, seven phone calls will be made once a week in the first month after discharge, and once a month in the eighth, twelfth and sixteenth weeks. Data will be collected by Mother-Baby Introductory Information Form, Breastfeeding Self-Efficacy Scale (short form) (BSES), Infant Feeding Attitude Scale (IIFAS) and Breastfeeding Time Assessment Form. The pre-test will be taken with the Mother-Baby Descriptive Information Form, BSES and IIFAS during the discharge routine procedures, and the post-test will be taken with the BSES, IIFAS and Breastfeeding Time Assessment Form when the baby is six months old. Ethics Committee and Institutional Permission was obtained for the study. In addition, written consent will be obtained from the participants. Statistical analysis will be done using SPSS 23.0 and significance will be evaluated at p <0.05. Support will be received in the analysis phase of the Statistical Information Unit of Akdeniz University. It is anticipated that new information from research data will improve breastfeeding results of premature babies and guide new research.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth, Breastfeeding
Keywords
Telephone based support,

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a pretest-posttest designed randomized controlled trial using the stratified block randomization method.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Sending breastfeeding guidelines for premature babies to phones after the discharge procedure is completed.and implementing a "Telephone Breastfeeding Support Program".
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Sending breastfeeding guidelines for premature babies to phones after the discharge procedure is completed.
Intervention Type
Behavioral
Intervention Name(s)
Telephone Breastfeeding Support Program
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Sending a breastfeeding guide for premature babies to the phone of mothers in addition to the routine discharge procedure
Intervention Description
In addition to the routine discharge procedure, a breastfeeding guide for premature babies will be sent to the mothers' phone.
Primary Outcome Measure Information:
Title
Breastfeeding Self-Efficacy Scale (short form)
Description
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.
Time Frame
0-6 months (During discharge routine procedures and when the baby is six months old)
Title
Infant Feeding Attitude Scale
Description
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.
Time Frame
0-6 months (During discharge routine procedures and when the baby is six months old)
Title
3. Breastfeeding Time Evaluation Form Breastfeeding Time Evaluation Form Breastfeeding Time Evaluation Form
Description
Prepared by researcher to find out breastfeeding status when babies are 6 months old.
Time Frame
When the baby is six months old

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Child, Adult, Older Adult
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Mothers with previous experience of breastfeeding a premature baby, Plural baby, Mother's breastfeeding disability (according to hospital records).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ezgi Boz, Postgraduate
Phone
+905398578928
Email
ezgi.boz96@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Arzu Akcan, PhD
Phone
+905334436659
Ext
+902423106108
Email
aarzu@akdeniz.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arzu Akcan, PhD
Organizational Affiliation
+905334436659
Official's Role
Study Director
Facility Information:
Facility Name
Akdeniz University
City
Antalya
ZIP/Postal Code
07000
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phone Breastfeeding Support for Premature Babies

We'll reach out to this number within 24 hrs