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The purpose of this study is to evaluate the safety and efficacy of Domperidone in those mothers who are identified as having difficulty with breast milk production to meet the nutritional needs of their infant in the neonatal intensive are unit hospitalization setting, and to determine how it should be considered in the care of mothers and their preterm infants without causing undesirable effects to either the mother or infant.
It is widely acknowledged that recent perinatal and neonatal technological advances (eg. assisted ventilation, surfactant, antenatal corticosteroids) have greatly enhanced the survival rate of very low birth weight and extremely low birth weight infants. A compelling body of evidence now exists to suggest that use of breast milk to feed preterm infants during initial hospitalization positively impacts their neurodevelopment during early childhood and beyond. In order to provide breastmilk, mothers of preterm infants have to begin to produce and mechanically express milk. However, these mothers are often faced with challenges in maintaining an adequate volume that will meet their infants' nutritional needs, as well as declines in production after several weeks despite a myriad of measures designed to assist in production. The primary hypothesis for this study is that Domperidone, through its pharmacologic action on increasing prolactin levels, will assist mothers experiencing inadequate breast milk production in increasing breast milk volumes to a level identified as being sufficient for continued pumping in the hospitalization period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Domperidone for days 1 to 28 | Experimental | Domperidone maleate tablets 10 mg orally three times daily from days 1 to 28 |
|
| Placebo for days 1 to 14 and domperidone for day 15-28 | Placebo Comparator | Identical placebo tablets 10 mg orally three times daily from days 1 to 14 followed by Domperidone maleate tablets 10 mg orally three times daily from days 15 to 28 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Domperidone maleate | Drug | domperidone maleate tablet 10 mg orally three times daily for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Increase in Breast Milk Production | 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). | Day 0 to day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in Breast Milk Volume on Day 28 | Number of mothers who achieved 50% increase in milk volume on day 28 | day 0 to day 28 |
| Mean Breast Milk Volumes on Day 14 | Mean milk volumes between the two groups at 14 days of study intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth V Asztalos, MD | Sunnybrook Research Institute | Principal Investigator |
| Marsha Campbell-Yeo, PhD | IWK Health Centre | Principal Investigator |
| Orlando Da Silva, MD | Children's Hospital, London Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28107101 | Result | Asztalos EV, Campbell-Yeo M, da Silva OP, Ito S, Kiss A, Knoppert D; EMPOWER Study Collaborative Group. Enhancing Human Milk Production With Domperidone in Mothers of Preterm Infants. J Hum Lact. 2017 Feb;33(1):181-187. doi: 10.1177/0890334416680176. Epub 2017 Jan 20. | |
| 31171928 | Derived | Asztalos EV, Kiss A, daSilva OP, Campbell-Yeo M, Ito S, Knoppert D; EMPOWER Study Collaborative Group. Role of days postdelivery on breast milk production: a secondary analysis from the EMPOWER trial. Int Breastfeed J. 2019 Jun 4;14:21. doi: 10.1186/s13006-019-0215-z. eCollection 2019. |
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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.
Recruitment took place from June 1, 2012 to June 30, 2015 in 8 Neonatal Intensive Care Units in Canada
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Group B: Placebo + Domperidone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Increase in Breast Milk Production | 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). | Posted | Count of Participants | Participants | Day 0 to day 14 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedRa | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elizabeth Asztalos | Sunnybrook Research Institute | 416-480-6100, | 87791 | elizabeth.asztalos@sunnybrook.ca |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D004294 | Domperidone |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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| Placebo Tablet | Drug | placebo tablet 10 mg orally three times daily for 14 days |
|
| Domperidone maleate | Drug | domperidone maleate tablet 10 mg orally three times daily for 14 days |
|
| Day 0 and day 14 |
| Mean Breast Milk Volumes on Day 28 | Mean milk volumes between the two groups at 28 days of study intervention | day 0 and 28 |
| Mean Volume Change From Day 0 to Day 14 | change on the volume of milk from day 0 to day 14 between the two groups | days 0 and 14 |
| Mean Volume Change on the Volume of Milk From Day 15 to Day 28 | change on the volume of milk from day 15 to day 28 between the two groups | day 15 and day 28 |
| Provision of Breast Milk at Term Gestation | provision of breast milk as the primary source of nutrition | term gestation |
| Provision of Breast Milk at 6 Weeks Post Term Gestation | Provision of breast milk at 6 weeks post term gestation as primary source of nutrition | 6 weeks post term gestation |
| 30543461 | Derived | Asztalos EV, Kiss A, daSilva OP, Campbell-Yeo M, Ito S, Knoppert D; <italic>EMPOWER</italic> Study Collaborative Group. Evaluating the Effect of a 14-Day Course of Domperidone on Breast Milk Production: A Per-Protocol Analysis from the EMPOWER Trial. Breastfeed Med. 2019 Mar;14(2):102-107. doi: 10.1089/bfm.2018.0175. Epub 2018 Dec 13. |
| 30410781 | Derived | Asztalos EV, Kiss A, da Silva OP, Campbell-Yeo M, Ito S, Knoppert D; EMPOWER Study Collaborative Group. Pregnancy gestation at delivery and breast milk production: a secondary analysis from the EMPOWER trial. Matern Health Neonatol Perinatol. 2018 Nov 5;4:21. doi: 10.1186/s40748-018-0089-x. eCollection 2018. |
| 22935052 | Derived | Asztalos EV, Campbell-Yeo M, daSilva OP, Kiss A, Knoppert DC, Ito S. Enhancing breast milk production with Domperidone in mothers of preterm neonates (EMPOWER trial). BMC Pregnancy Childbirth. 2012 Aug 31;12:87. doi: 10.1186/1471-2393-12-87. |
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
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Ethnicity was self-declared | Count of Participants | Participants |
|
| Parity | Count of Participants | Participants |
|
| Type of pregnancy | Count of Participants | Participants |
|
| Mean milk Volume at entry | Mean | Standard Deviation | millilitres |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Increase in Breast Milk Volume on Day 28 | Number of mothers who achieved 50% increase in milk volume on day 28 | Posted | Count of Participants | Participants | day 0 to day 28 |
|
|
|
| Secondary | Mean Breast Milk Volumes on Day 14 | Mean milk volumes between the two groups at 14 days of study intervention | Posted | Mean | Standard Deviation | millilitres | Day 0 and day 14 |
|
|
|
| Secondary | Mean Breast Milk Volumes on Day 28 | Mean milk volumes between the two groups at 28 days of study intervention | Posted | Mean | Standard Deviation | millilitres | day 0 and 28 |
|
|
|
| Secondary | Mean Volume Change From Day 0 to Day 14 | change on the volume of milk from day 0 to day 14 between the two groups | Posted | Mean | Full Range | millilitres | days 0 and 14 |
|
|
|
| Secondary | Mean Volume Change on the Volume of Milk From Day 15 to Day 28 | change on the volume of milk from day 15 to day 28 between the two groups | Posted | Mean | Full Range | millilitres | day 15 and day 28 |
|
|
|
| Secondary | Provision of Breast Milk at Term Gestation | provision of breast milk as the primary source of nutrition | Posted | Count of Participants | Participants | term gestation |
|
|
|
| Secondary | Provision of Breast Milk at 6 Weeks Post Term Gestation | Provision of breast milk at 6 weeks post term gestation as primary source of nutrition | Posted | Count of Participants | Participants | 6 weeks post term gestation |
|
|
|
| 0 |
| 45 |
| 10 |
| 45 |
| EG001 | 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 | 0 | 45 | 3 | 45 |
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| D000091642 | Urogenital Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |