Trial Outcomes & Findings for Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates (NCT NCT01512225)

NCT ID: NCT01512225

Last Updated: 2017-04-20

Results Overview

The primary outcome is the difference in the proportion of women having a 50% increase in breast milk volume at the end of 14 days of treatment with domperidone compared to mothers receiving placebo (mean day 14 volume minus mean day 0 volume at entry).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 90 participants
• Primary outcome timeframe: Day 0 to day 14
• Results posted on: 2017-04-20

Participant Flow

Recruitment took place from June 1, 2012 to June 30, 2015 in 8 Neonatal Intensive Care Units in Canada

Mothers could be identified in the NICU as early as day 4 until day 18 post-delivery. Additional counseling and support by the lactation consultant with respect to non-pharmacologic techniques were offered. If there was no response to the techniques, the mother was considered eligible for the trial.

Participant milestones

Measure	Group A: Domperidone Domperidone 10 mg orally three times daily for 28 days Domperidone maleate: domperidone 10 mg orally three times daily for 28 days	Group B: Placebo + Domperidone Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
Overall Study STARTED	45	45
Overall Study Provided Day 14 Volume	45	40
Overall Study COMPLETED	45	45
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates

Baseline characteristics by cohort

Measure	Group A: Domperidone n=45 Participants Domperidone 10 mg orally three times daily for 28 days Domperidone maleate: domperidone 10 mg orally three times daily for 28 days	Group B: Placebo + Domperidone n=45 Participants Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days	Total n=90 Participants Total of all reporting groups
Age, Continuous	31.25 years n=5 Participants	33.56 years n=7 Participants	32.41 years n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	45 Participants n=7 Participants	90 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	29 Participants n=5 Participants	30 Participants n=7 Participants	59 Participants n=5 Participants
Race/Ethnicity, Customized Black	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Asian	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Aboriginal	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Parity 0	28 Participants n=5 Participants	33 Participants n=7 Participants	61 Participants n=5 Participants
Parity >/= 1	17 Participants n=5 Participants	12 Participants n=7 Participants	29 Participants n=5 Participants
Type of pregnancy Singleton	38 Participants n=5 Participants	39 Participants n=7 Participants	77 Participants n=5 Participants
Type of pregnancy Twins	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Mean milk Volume at entry	121 millilitres STANDARD_DEVIATION 96 • n=5 Participants	115 millilitres STANDARD_DEVIATION 95 • n=7 Participants	118 millilitres STANDARD_DEVIATION 96 • n=5 Participants

PRIMARY outcome

Timeframe: Day 0 to day 14

The primary outcome is the difference in the proportion of women having a 50% increase in breast milk volume at the end of 14 days of treatment with domperidone compared to mothers receiving placebo (mean day 14 volume minus mean day 0 volume at entry).

Outcome measures

Measure	Group A: Domperidone n=45 Participants Domperidone 10 mg orally three times daily for 28 days	Group B: Placebo + Domperidone n=45 Participants Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
Increase in Breast Milk Production	35 Participants	26 Participants

SECONDARY outcome

Timeframe: day 0 to day 28

Number of mothers who achieved 50% increase in milk volume on day 28

Outcome measures

Measure	Group A: Domperidone n=45 Participants Domperidone 10 mg orally three times daily for 28 days	Group B: Placebo + Domperidone n=45 Participants Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
Increase in Breast Milk Volume on Day 28	31 Participants	28 Participants

SECONDARY outcome

Timeframe: Day 0 and day 14

Mean milk volumes between the two groups at 14 days of study intervention

Outcome measures

Measure	Group A: Domperidone n=45 Participants Domperidone 10 mg orally three times daily for 28 days	Group B: Placebo + Domperidone n=45 Participants Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
Mean Breast Milk Volumes on Day 14	267 millilitres Standard Deviation 189	217 millilitres Standard Deviation 168

SECONDARY outcome

Timeframe: day 0 and 28

Mean milk volumes between the two groups at 28 days of study intervention

Outcome measures

Measure	Group A: Domperidone n=45 Participants Domperidone 10 mg orally three times daily for 28 days	Group B: Placebo + Domperidone n=45 Participants Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
Mean Breast Milk Volumes on Day 28	290 millilitres Standard Deviation 211	302 millilitres Standard Deviation 230

SECONDARY outcome

Timeframe: days 0 and 14

change on the volume of milk from day 0 to day 14 between the two groups

Outcome measures

Measure	Group A: Domperidone n=45 Participants Domperidone 10 mg orally three times daily for 28 days	Group B: Placebo + Domperidone n=45 Participants Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
Mean Volume Change From Day 0 to Day 14	254 millilitres Interval -100.0 to 2129.0	175 millilitres Interval -100.0 to 923.0

SECONDARY outcome

Timeframe: day 15 and day 28

change on the volume of milk from day 15 to day 28 between the two groups

Outcome measures

Measure	Group A: Domperidone n=45 Participants Domperidone 10 mg orally three times daily for 28 days	Group B: Placebo + Domperidone n=45 Participants Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
Mean Volume Change on the Volume of Milk From Day 15 to Day 28	22 millilitres Interval -68.0 to 200.0	49 millilitres Interval -100.0 to 254.0

SECONDARY outcome

Timeframe: term gestation

provision of breast milk as the primary source of nutrition

Outcome measures

Measure	Group A: Domperidone n=45 Participants Domperidone 10 mg orally three times daily for 28 days	Group B: Placebo + Domperidone n=45 Participants Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
Provision of Breast Milk at Term Gestation	26 Participants	27 Participants

SECONDARY outcome

Timeframe: 6 weeks post term gestation

Provision of breast milk at 6 weeks post term gestation as primary source of nutrition

Outcome measures

Measure	Group A: Domperidone n=45 Participants Domperidone 10 mg orally three times daily for 28 days	Group B: Placebo + Domperidone n=45 Participants Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
Provision of Breast Milk at 6 Weeks Post Term Gestation	19 Participants	20 Participants

Adverse Events

Group A: Domperidone

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Group B: Placebo + Domperidone

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group A: Domperidone n=45 participants at risk Domperidone 10 mg orally three times daily for 28 days Domperidone maleate: domperidone 10 mg orally three times daily for 28 days	Group B: Placebo + Domperidone n=45 participants at risk Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
Nervous system disorders Headache	22.2% 10/45 • Number of events 31	6.7% 3/45 • Number of events 23

Additional Information

Dr. Elizabeth Asztalos

Sunnybrook Research Institute

Phone: 416-480-6100,

Email: elizabeth.asztalos@sunnybrook.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place