|
Welcome
|
|
11 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| ADEPT - Abnormal Doppler Enteral Prescription Trial |
| ISRCTN | ISRCTN87351483 |
| ClinicalTrials.gov identifier | |
| Public title | ADEPT - Abnormal Doppler Enteral Prescription Trial |
| Scientific title | Randomised controlled trial of early versus late initiation of milk feeds for infants with absent or reversed end diastolic flow velocities (AREDFV) or cerebral redistribution |
| Acronym | ADEPT |
| Serial number at source | SP4006 |
| Study hypothesis |
The aim is to evaluate the effects of an 'early' enteral feeding regimen, starting milk feeds on day 2 after birth (between 24 and 48 hours of age) compared to one of 'late' introduction of enteral feeds, starting feeds on day 6 after birth (between 120 - 144 hours of age) in a group of babies identified as being at high risk for necrotising enterocolitis (NEC) and milk intolerance by antenatal Doppler studies.
Added 23/11/2007: Please note that due to an extension in funding from Action Medical Research the anticipated end date of this trial has been extended to 31/12/2008. The previous end date of this trial was 05/03/2008. |
| Lay summary | |
| Ethics approval | Oxfordshire Research Ethics Committee (REC) C gave approval on the 27th September 2005 (ref: 05/Q1606/121) |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Nutrition |
| Participants - inclusion criteria |
Infants admitted to participating neonatal units and satisfying all of the following criteria may be recruited into the study:
1. Gestational age up to and including 34 weeks + 6 days 2. Antenatal ultrasound showing either: 2.1. Absent or reversed end diastolic flow velocities on at least 50% of the Doppler waveforms from the umbilical artery on at least one occasion during pregnancy, or 2.2. Cerebral redistribution, defined as occurring when both the umbilical artery pulsatility index is greater than the 95th centile and the middle cerebral artery pulsatility index is less that the 5th centile for gestational age 3. Small for gestational age 4. Postnatal age 20 - 48 hours |
| Participants - exclusion criteria |
Infants will be excluded if any of the following factors are present:
1. Major congenital abnormality including known chromosomal abnormality 2. Twin-twin transfusion 3. Intra-uterine transfusion or exchange transfusion 4. Rhesus iso-immunisation 5. Significant multi-organ failure prior to trial entry 6. Inotropic drug support prior to trial entry 7. Already received any enteral feeding |
| Anticipated start date | 01/09/2005 |
| Anticipated end date | 31/12/2008 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 400 babies |
| Interventions | Feeding of preterm infants after absent or reversed end-diastolic flow velocities (AREDFV). Babies will be randomly allocated to an 'early' or 'late' enteral feeding regimen. These will start milk feeds on day 2 and day 6 after birth, respectively. |
| Primary outcome measure(s) |
1. Age in days at which full enteral feeding sustained for 72 hours was reached
2. Necrotising enterocolitis, stage I, II or III |
| Secondary outcome measure(s) |
1. Death before hospital discharge
2. Duration of hospital stay 3. Duration of intensive and high dependency care 4. Duration of parenteral nutrition 5. Change in Z score for weight and head circumference from birth to 36 weeks postmenstrual age and from birth to discharge 6. In continuous supplemental oxygen at 36 weeks post-menstrual age 7. Confirmed bacterial sepsis 8. Gastrointestinal perforation 9. Gastrointestinal surgery 10. Cholestasis (defined as greater than 25 μmol/l conjugated fraction of serum bilirubin) 11. Patent ductus arteriosus requiring pharmacological or surgical treatment 12. Type of milk at discharge 13. On oxygen therapy at discharge This information is collected prior to the baby being discharged home. |
| Sources of funding | Action Medical Research (UK) |
| Trial website | http://www.action.org.uk/research_projects/grant/257/ |
| Publications | 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19799788 |
| Contact name | Dr Alison Leaf |
| Address |
Consultant Neonatologist
Southmead Hospital |
| City/town | Bristol |
| Zip/Postcode | BS10 5NB |
| Country | United Kingdom |
| Tel | +44 (0)117 9596141 |
| alison.leaf@nbt.nhs.uk | |
| Sponsor | University of Oxford (UK) |
| Address |
University Offices
Wellington Square |
| City/town | Oxford |
| Zip/Postcode | OX1 2JD |
| Country | United Kingdom |
| Tel | +44 (0)1865 270000 |
| research.services@admin.ox.ac.uk | |
| Sponsor website: | http://www.ox.ac.uk |
| Date applied | 30/09/2004 |
| Last edited | 20/01/2010 |
| Date ISRCTN assigned | 30/09/2004 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|