Condition category
Neonatal Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Alison Leaf


Contact details

Consultant Neonatologist
Southmead Hospital
BS10 5NB
United Kingdom
+44 (0)117 9596141

Additional identifiers

EudraCT number number

Protocol/serial number


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



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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet




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



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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Consultant Neonatologist
BS10 5NB
United Kingdom

Sponsor information


University of Oxford (UK)

Sponsor details

University Offices
Wellington Square
United Kingdom
+44 (0)1865 270000

Sponsor type




Funder type


Funder name

Action Medical Research (UK)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations


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:
2012 results in:
2014 results in:

Publication citations

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes