The Effect of Breastfeeding Support System

Breastfeeding Clinical Trial

Official title:

The Effect of Breastfeeding Support System on Breast Milk Quantity and Mother-Infant Bonding in Preterm Infants: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06003959
• Other study ID #: Sumeyye
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was conducted to investigate the effect of a breastfeeding support system on breast milk quantity and mother-infant attachment in preterm infants. This randomized controlled experimental study was conducted in the Level III Neonatal Intensive Care Unit (NICU) of a hospital in eastern Turkey between January and June 2022. The population of the study consisted of preterm infants and their mothers who received treatment and care in the NICU between the dates of the study. The study sample consisted of 70 preterm infants (35 experimental, 35 control) and their mothers who met the research criteria.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Months to 34 Months

Eligibility

Inclusion Criteria:

• For the baby
• Gestation week between 30 weeks and 34 weeks,
• Birth weight of 1000 g and above,
• Spontaneous respiration,
• His vital signs are stable,
• Born with a 5-minute APGAR of 7 and above,
• Gavage-fed exclusively with breast and/or formula milk and ready to be switched to oral feeding,
• Grade III and IV intracranial hemorrhage and no periventricular locomosis,
• No known congenital diseases,
• Severe asphyxia, without chronic lung disease,
• Babies who did not develop NEC were included in the study. For mothers
• Over 18 years of age, literate, able to speak Turkish,
• Mothers who were willing to breastfeed and did not have a chronic disease that prevented breastfeeding were included in the study.

Exclusion Criteria:

• Unidentified babies,
• Infants with unstable vital signs,
• Mothers with an obstacle to breastfeeding were excluded.

Related Conditions & MeSH terms

• Breast Milk
• Breastfeeding
• Premature Birth
• Preterm

Intervention

Other:
• Routine nursing care
Preterm infants in the control group did not receive any intervention other than the routine feeding protocol applied in the clinic. Body weights of the babies were measured and recorded in the morning before the first feeding. The amount of breast milk to be given for feeding according to the clinic protocol was determined by the physician and the babies were fed with a bottle. The mothers of preterm infants were asked to fill out the Mother-Infant Attachment Scale before and after the feeding of their infants. These interventions were continued until the baby was fully breastfed.
• breastfeeding support system
Body weight of preterm infants in the experimental group was measured and recorded in the morning before the first feeding. The mothers of preterm infants were asked to fill out the Mother-Infant Attachment Scale in the pre-procedure period. The amount of breast milk that the preterm infant should receive during feeding was determined by the physician. Before feeding, the neonatal nurse ensured sterile preparation of the milk and transferred it to the Breastfeeding Support System. The mothers were then prepared for the procedure. Accordingly, the breastfeeding support system was explained to the mother by the specialized neonatal nurse. When the preparation of the mother and baby was completed, the baby was placed on the mother's breast. After feeding, the mother was asked to fill out the Mother-Infant Attachment Scale the again. These interventions were continued until the baby was fully transferred to the mother's breast.

Locations

Country	Name	City	State
Turkey	Sümeyye EKICI	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mother-Infant Attachment Scale	The Turkish validity and reliability of this scale developed by Taylor et al. in 2005 was conducted by Aydemir Karakulak and Alparslan (2016). It is a scale that allows the mother to express her feelings towards her baby with a single word. This scale, which can be applied from the first day after birth, can be easily and quickly applied by the mother. The scale has 8 items and four Likert-type items. A score between 0 and 24 can be obtained from the scale. An increase in the score indicates that there is an attachment problem between the mother and the infant. Cronbach Alpha internal consistency coefficients of the scale were found to be 0.69 in the first stage and 0.68 in the second stage	up to 6 months