Condition category
Neonatal Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
14/02/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.action.org.uk/research_projects/grant/257/

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 measures

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

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

http://www.ox.ac.uk

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

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

Results - basic reporting

Publication summary

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

  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