Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Alison Leaf
ORCID ID
Contact details
Consultant Neonatologist
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
+44 (0)117 9596141
alison.leaf@nbt.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SP4006
Study information
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
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.
Ethics approval
Oxfordshire Research Ethics Committee (REC) C gave approval on the 27th September 2005 (ref: 05/Q1606/121)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/09/2005
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
400 babies
Participant 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
Recruitment start date
01/09/2005
Recruitment end date
31/12/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Consultant Neonatologist
Bristol
BS10 5NB
United Kingdom
Sponsor information
Organisation
University of Oxford (UK)
Sponsor details
University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom
+44 (0)1865 270000
research.services@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Action Medical Research (UK)
Alternative name(s)
AMR
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19799788
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22492770
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23973795
Publication citations
-
Protocol
Leaf A, Dorling J, Kempley S, McCormick K, Mannix P, Brocklehurst P, ADEPT - Abnormal Doppler Enteral Prescription Trial., BMC Pediatr, 2009, 9, 63, doi: 10.1186/1471-2431-9-63.
-
Results
Leaf A, Dorling J, Kempley S, McCormick K, Mannix P, Linsell L, Juszczak E, Brocklehurst P, , Early or delayed enteral feeding for preterm growth-restricted infants: a randomized trial., Pediatrics, 2012, 129, 5, e1260-8, doi: 10.1542/peds.2011-2379.
-
Results
Kempley S, Gupta N, Linsell L, Dorling J, McCormick K, Mannix P, Juszczak E, Brocklehurst P, Leaf A, , Feeding infants below 29 weeks' gestation with abnormal antenatal Doppler: analysis from a randomised trial., Arch. Dis. Child. Fetal Neonatal Ed., 2014, 99, 1, F6-F11, doi: 10.1136/archdischild-2013-304393.