Phone Breastfeeding Support for Premature Babies

NCT ID: NCT04883866

Last Updated: 2021-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-07-01

Brief Summary

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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

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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.

Conditions

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Preterm Birth Breastfeeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a pretest-posttest designed randomized controlled trial using the stratified block randomization method.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Intervention Group

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

Group Type EXPERIMENTAL

Telephone Breastfeeding Support Program

Intervention Type BEHAVIORAL

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.

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

Intervention Type BEHAVIORAL

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

Control Group

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

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Interventions

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Telephone Breastfeeding Support Program

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

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

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Ezgi Boz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arzu Akcan, PhD

Role: STUDY_DIRECTOR

+905334436659

Locations

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Akdeniz University

Antalya, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ezgi Boz, Postgraduate

Role: CONTACT

+905398578928

Arzu Akcan, PhD

Role: CONTACT

+905334436659 ext. +902423106108

Other Identifiers

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KAEK- 118

Identifier Type: -

Identifier Source: org_study_id

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