Milk Production Clinical Trial
Official title:
Randomised Trial Comparing the Efficacy of the ISIS Duo iQ Electric Breast Pump and the Medela Symphony Electric Breast Pump in Mothers Expressing Breast Milk for Preterm Infants
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
| Status | Recruiting |
| Enrollment | 176 |
| Est. completion date | February 2010 |
| Est. primary completion date | July 2009 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Mothers who have delivered, preterm (before 34 weeks) infants who plan to express breast milk for their infant(s). Their infants will need to be less than 72 hours old prior to enrolment and likely to remain in NICUs for at least 10 days. Exclusion Criteria: - Other mothers not fitting inclusion criteria. |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Institute of Child Health, 30 Guilford Street | London |
| Lead Sponsor | Collaborator |
|---|---|
| Institute of Child Health |
United Kingdom,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Total weight of milk expressed during the first 10 days post-partum. | 10 days post-partum | No | |
| Primary | Weight of milk collected at 1 minute intervals over a 15 minute period on Day 5. | 10 days post-partum | No | |
| Primary | Time taken to express a fixed volume of milk. | 10 days post-partum | No | |
| Primary | Time taken for first milk to appear. | 10 days post-partum | No | |
| Secondary | Total number of pumping sessions to Day 10. | 10 days | No | |
| Secondary | Total time spent expressing to Day 10. | 10 days | No | |
| Secondary | Mothers' opinions of the assigned pumps on Day 10. | 1 day | No | |
| Secondary | Volume of milk expressed whilst on neonatal unit. | 10 days | No | |
| Secondary | Number of days taken to reach full enteral feeds. | 10 or more days | No |