Clinical trial NCT04883866: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Birth
Breastfeeding
Keywords: Telephone based support,
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 62
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pretest-posttest designed randomized controlled trial using the stratified block randomization method.
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Breastfeeding Self-Efficacy Scale (short form)
timeFrame: 0-6 months (During discharge routine procedures and when the baby is six months old)
measure: Infant Feeding Attitude Scale
timeFrame: 0-6 months (During discharge routine procedures and when the baby is six months old)
measure: 3. Breastfeeding Time Evaluation Form Breastfeeding Time Evaluation Form Breastfeeding Time Evaluation Form
timeFrame: When the baby is six months old
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
affiliation: +905334436659
name: Arzu Akcan, PhD
role: STUDY_DIRECTOR
References: