Phone Breastfeeding Support for Premature Babies

Preterm Birth Clinical Trial

Official title:

Impact of Telephone Breastfeeding Support on Breastfeeding Outcomes for Mothers With Premature Babies: Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04883866
• Other study ID #: KAEK- 118
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2021
• Source: Akdeniz University
• Contact: Ezgi Boz, Postgraduate
• Phone: +905398578928
• Email: ezgi.boz96[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: July 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Breastfeeding
• Premature Birth
• Preterm Birth

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breastfeeding Self-Efficacy Scale (short form)	The scale, which is valid and reliable in our country by Alus¸ 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)
Primary	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)
Primary	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