ADEPT - Abnormal Doppler Enteral Prescription Trial

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN87351483

Enrollment

400

Registered

2004-09-30

Start date

2005-09-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition Neonatal Diseases

Interventions

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 fee

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1. Age in days at which full enteral feeding sustained for 72 hours was reached 2. Necrotising enterocolitis, stage I, II or III	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026