ADEPT - Abnormal Doppler Enteral Prescription Trial
| ISRCTN | ISRCTN87351483 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87351483 |
| Secondary identifying numbers | SP4006 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 14/02/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Alison Leaf
Scientific
Scientific
Consultant Neonatologist
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
| Phone | +44 (0)117 9596141 |
|---|---|
| alison.leaf@nbt.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | ADEPT |
| Study objectives | 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. |
| Ethics approval(s) | Oxfordshire Research Ethics Committee (REC) C gave approval on the 27th September 2005 (ref: 05/Q1606/121) |
| Health condition(s) or problem(s) studied | Nutrition |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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. |
| Overall study start date | 01/09/2005 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 400 babies |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 31/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Consultant Neonatologist
Bristol
BS10 5NB
United Kingdom
BS10 5NB
United Kingdom
Sponsor information
University of Oxford (UK)
University/education
University/education
University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
| Phone | +44 (0)1865 270000 |
|---|---|
| research.services@admin.ox.ac.uk | |
| Website | http://www.ox.ac.uk |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
Action Medical Research (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- actionmedres, action medical research for children, AMR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 02/10/2009 | Yes | No | |
| Results article | results | 01/05/2012 | Yes | No | |
| Results article | results | 01/01/2014 | Yes | No |
