ADEPT - Abnormal Doppler Enteral Prescription Trial

ISRCTN	ISRCTN87351483
DOI	https://doi.org/10.1186/ISRCTN87351483
Protocol serial number	SP4006
Sponsor	University of Oxford (UK)
Funder	Action Medical Research (UK)

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

Consultant Neonatologist
Southmead Hospital
Bristol
BS10 5NB
United Kingdom

Phone	+44 (0)117 9596141
Email	alison.leaf@nbt.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	1. Age in days at which full enteral feeding sustained for 72 hours was reached 2. Necrotising enterocolitis, stage I, II or III
Key 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.
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	400
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

United Kingdom
England

Study participating centre

Consultant Neonatologist

Bristol
BS10 5NB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2012		Yes	No
Results article	results	01/01/2014		Yes	No
Protocol article	protocol	02/10/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes