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Status unknownNCT04883866Updated Jul 22, 2021

Phone Breastfeeding Support for Premature Babies

An interventional study of Telephone Breastfeeding Support Program and Sending a breastfeeding guide for premature babies to the phone of mothers in addition to the routine discharge procedure in Preterm Birth and Breastfeeding, sponsored by Akdeniz University. Status unknown at 1 site in Turkey. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-22.

Sponsored by Akdeniz University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Preterm Birth
  • Breastfeeding

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Keywords

  • Telephone based support,
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's planned enrollment of 62 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Akdeniz University is the lead sponsor of 289 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Mothers with previous experience of breastfeeding a premature baby,
  • Plural baby,
  • Mother's breastfeeding disability (according to hospital records).
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
62 participants (estimated)

Study arms

  • Experimental
    Intervention Group

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

  • Experimental
    Control Group

    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

  • BehavioralTelephone 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.

  • BehavioralSending 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.

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

    Time frame: When the baby is six months old

07

Study locations

1 of 1 sites recruiting
  • Akdeniz University
    Antalya, 07000, Turkey
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04883866
Lead sponsor
Akdeniz University
Responsible party
Ezgi Boz (Principal Investigator, Akdeniz University) — Principal investigator
First posted
May 12, 2021
Start date
Jun 1, 2021
Primary completion
Dec 1, 2021 (estimated)
Completion
Jul 1, 2022 (estimated)
Last update
Jul 22, 2021

Study contacts

Ezgi Boz, Postgraduate
Contact
ezgi.boz96@gmail.com
+905398578928
Arzu Akcan, PhD
Contact
aarzu@akdeniz.edu.tr
+905334436659 ext. +902423106108
Arzu Akcan, PhD
study director · +905334436659

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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