Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT00308334
Eligibility Criteria:
Inclusion Criteria:
* i. Mother of an infant born less than 31 weeks gestation
* ii. Women mechanically expressing breast milk using a double collecting system
* iii. Experiencing lactation failure indicated by at least one of the following: A decreasing milk supply (by greater than 30 percent from peak volume based on maternal account) An inability to provide adequate breast milk to meet the daily nutritional intake of their infant
* iv. Women who have had little or no improvement in milk production following education/counseling with a lactation consultant/Neonatal Intensive Care nurse with respect to non-pharmacological techniques.
* v. Postpartum period equal to or greater than three weeks.
Exclusion Criteria:
* i. Participants receiving any medication known to alter the effect of domperidone (e.g.cimetidine, ranitidine, famotidine, and nizatidine) or medication that interacts with domperidone (e.g. haloperidol, lithium).
* ii. Experiencing mastitis
* iii. Having a chronic or debilitating illness.
* iv. Previous breast surgery
* v. Having a known lactose intolerance
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00308334
Study Brief:
Protocol Section:
NCT00308334