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This is a randomised controlled trial investigating the performance of two, 'state of the art' electric breast pumps in mothers who have delivered preterm infants. The main data collection period will be up to day 10 post delivery data. Data collected will include a record of the weight of milk produced during the first 10 days and a short questionnaire to find the mothers' opinions of the pumps used. On Day 5 a timed and weighed expression of 15 minutes will be carried out. After the first 10 days, mothers will be asked to collect brief information on their continuing use of their pumps and subsequent duration of breast and bottle feeding, mothers will be contacted at 3 and 6 months post-term
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electric Pump 1 (ISIS Duo iQ Electric Breast Pump) | This is a parallel trial where subjects (mother of preterm infants) will be allocated to use one of two electric breast pumps to express milk. The use of electric breast pumps is routine practice on neonatal units in the UK. | ||
| Electric Pump 2 (Medela Symphony Electric Breast Pump) | This is a parallel trial where subjects (mother of preterm infants) will be allocated to use one of two electric breast pumps to express milk. The use of electric breast pumps is routine practice on neonatal units in the UK. |
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| Measure | Description | Time Frame |
|---|---|---|
| Total weight of milk expressed during the first 10 days post-partum. | 10 days post-partum | |
| Weight of milk collected at 1 minute intervals over a 15 minute period on Day 5. | 10 days post-partum | |
| Time taken to express a fixed volume of milk. | 10 days post-partum | |
| Time taken for first milk to appear. | 10 days post-partum |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of pumping sessions to Day 10. | 10 days | |
| Total time spent expressing to Day 10. | 10 days | |
| Mothers' opinions of the assigned pumps on Day 10. |
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Inclusion Criteria:
Exclusion Criteria:
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This is a parallel trial where subjects (mother of preterm infants) will be allocated to use one of two electric breast pumps to express milk.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pat Burton | Contact | P.Burton@ich.ucl.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Mary Fewtrell, Dr | Institute of Child Health | Principal Investigator |
| Pat Burton | Institute of Child Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Child Health, 30 Guilford Street | Recruiting | London | WC1N 1EH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11389245 | Background | Fewtrell MS, Lucas P, Collier S, Singhal A, Ahluwalia JS, Lucas A. Randomized trial comparing the efficacy of a novel manual breast pump with a standard electric breast pump in mothers who delivered preterm infants. Pediatrics. 2001 Jun;107(6):1291-7. doi: 10.1542/peds.107.6.1291. | |
| 26936878 | Derived | Fewtrell MS, Kennedy K, Ahluwalia JS, Nicholl R, Lucas A, Burton P. Predictors of expressed breast milk volume in mothers expressing milk for their preterm infant. Arch Dis Child Fetal Neonatal Ed. 2016 Nov;101(6):F502-F506. doi: 10.1136/archdischild-2015-308321. Epub 2016 Mar 2. |
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| ID | Term |
|---|---|
| D061186 | Breast Milk Expression |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D007752 | Obstetric Labor, Premature |
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| 1 day |
| Volume of milk expressed whilst on neonatal unit. | 10 days |
| Number of days taken to reach full enteral feeds. | 10 or more days |
| 23776081 | Derived | Burton P, Kennedy K, Ahluwalia JS, Nicholl R, Lucas A, Fewtrell MS. Randomized trial comparing the effectiveness of 2 electric breast pumps in the NICU. J Hum Lact. 2013 Aug;29(3):412-9. doi: 10.1177/0890334413490995. Epub 2013 Jun 17. |
| D007744 |
| Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |