Investigating the effect of domperidone on breast milk supply following preterm birth- the SUMMIT follow-up study

Not Applicable

Recruiting

• Conditions: actation insufficiency; Preterm birth; Lactation insufficiency; Reproductive Health and Childbirth - Breast feeding; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12621000512820
• Lead Sponsor: South Australian Health and Medical Research Institute (SAHMRI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-03
• Last Update Posted: 25 March 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

All women who participated in the SUMMIT trial will be invited to participate. Selection criteria for SUMMIT include:
-Mothers of preterm infants born <34 weeks' gestation (up to 33+6)
-Lactation insufficiency defined as breast milk volume less than 300 mL/day in previous 24 hours if between 7 and 13 days postpartum, or breast milk volume less than 500 mL/day in previous 24 hours if between 14 and 28 days postpartum
-Between 7 and 28 days postpartum
-Expressing with an electric pump an average of 6 times a day or more in previous 24-48 hours
-Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessment and follow-up of mother and baby until infant discharge.
-Signed and written consent.

Exclusion Criteria

- Did not participate in SUMMIT RCT

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion breastfeeding or breast milk feeding (defined as the process of feeding a mother's breast milk to her infant, either directly from the breast or by expressing the milk from the breast and bottle-feeding it to the infant) - assessed by maternal self-report using a study-specific questionnaire[ Six months infant corrected age]