NCT00308334

Brief Summary

The purpose of this study is to evaluate the effect of domperidone (given to lactating mothers of very preterm infants) on the macronutrient composition of human milk.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

June 11, 2009

Status Verified

June 1, 2009

Enrollment Period

4.2 years

First QC Date

March 27, 2006

Last Update Submit

June 10, 2009

Conditions

Low Breast Milk Supply

Keywords

Domperidonebreast milkbreast milk compositionpreterm infantneonatenutrition

Outcome Measures

Primary Outcomes (1)

  • The protein levels from breast milk will be compared, between the two groups (taking into consideration the expected rate of decline associated with increasing postpartum days).

    days 0, 4, 7, and 14

Secondary Outcomes (5)

  • The fat, carbohydrate, lactose, energy, calcium, phosphorus and sodium content of breast milk will be compared between domperidone and placebo groups.

    days 0, 4, 7, and 14,

  • Breast milk volumes (if the infant breast feeds, volume will be estimated using pre and post feeding weights)

    Daily X 14 days

  • Serum prolactin level

    Day 0, 4 and 14

  • infant weights

    daily X 14 days

  • breastfeeding rates

    two weeks after treatment completion and at discharge

Study Arms (2)

Domperidone

EXPERIMENTAL

Domperidone

Drug: Domperidone

placeob- Sugar pill

PLACEBO COMPARATOR
Drug: Placebo- Sugar pill

Interventions

DomperidoneDRUG

10 mg po TID X 14 days

Domperidone
Placebo- Sugar pillDRUG

placebo po TID x 14 days

placeob- Sugar pill

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Related Publications (2)

  • Campbell-Yeo ML, Allen AC, Joseph KS, Ledwidge JM, Allen VM, Dooley KC. Study protocol: a double blind placebo controlled trial examining the effect of domperidone on the composition of breast milk [NCT00308334]. BMC Pregnancy Childbirth. 2006 May 23;6:17. doi: 10.1186/1471-2393-6-17.

    PMID: 16719919BACKGROUND

  • Campbell-Yeo ML, Allen AC, Joseph KS, Ledwidge JM, Caddell K, Allen VM, Dooley KC. Effect of domperidone on the composition of preterm human breast milk. Pediatrics. 2010 Jan;125(1):e107-14. doi: 10.1542/peds.2008-3441. Epub 2009 Dec 14.

    PMID: 20008425DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Domperidone

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Marsha L Campbell-Yeo, MN NNP-BC PhDc

    IWK Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 27, 2006

First Posted

March 29, 2006

Study Start

October 1, 2003

Primary Completion

December 1, 2007

Study Completion

January 1, 2008

Last Updated

June 11, 2009

Record last verified: 2009-06

Locations

CA(1)