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Clinical Trials/ACTRN12621000512820
ACTRN12621000512820
Recruiting
未知

SUpporting Mothers Milk Intervention Trial comparing different doses of domperidone for treating lactation insufficiency in mothers of preterm infants: A Follow-Up study (Post-SUMMIT)

South Australian Health and Medical Research Institute (SAHMRI)0 sites110 target enrollmentMay 3, 2021
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Conditionsactation insufficiencyPreterm birthLactation insufficiencyReproductive Health and Childbirth - Breast feedingReproductive Health and Childbirth - Complications of newborn

Overview

Phase
未知
Intervention
Not specified
Conditions
actation insufficiency
Sponsor
South Australian Health and Medical Research Institute (SAHMRI)
Enrollment
110
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 3, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
South Australian Health and Medical Research Institute (SAHMRI)

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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