Clinical trial NCT01367015: Early Versus Late Initiation of Feeding in Premature Growth Restricted Newborns With Absent or Reversed End Diastolic Flow On Umbilical Artery Doppler (AREDF)
Official title: A Randomized Clinical Trial on Comparison of Early Versus Late Initiation of Feeding in Preterm Small for Gestation Infants Below 35 Weeks Gestation With Prenatal Absent or Reversal of End Diastolic Flow (AREDF) in Umbilical Artery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prematurity of Fetus
Postnatal Growth Disorder
Keywords: Preterm
SGA
AREDF
Early feeding
Late feeding
Feed intolerance
Necrotizing enterocolitis
Days to achieve Full Feeds defined as 150 mL/kg
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Sir Ganga Ram Hospital
name: Maulana Azad Medical College
name: Vardhman Mahavir Medical College And Safdarjung Hospital
name: Fernandez Hospital
First posted: 2011-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 48
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to compare early versus late initiation of enteral feeding in premature growth restricted babies below the gestational age of 35 weeks born to mothers with prenatal absent or reversal of end diastolic flow in the umbilical artery. Normally the blood flow from the mother to the baby brings all the nutrients required for growth and the very vital oxygen required for survival. These deprived babies with poor blood flow adapt to the not so conducive uterine environment by certain adjustments in blood supply to internal organs. This permits the best possible blood flow to brain heart etc., which are the vital organs and whose adequate functioning is required for survival. As a consequence, the gut (intestines) gets poor blood supply and hence its appropriate functioning may be jeopardized. Such 'premature growth restricted' babies are at increased risk of further growth faltering if not fed adequately as also to a condition called 'Necrotising enterocolitis' if fed liberally like other healthy neonates, characterized by abdominal distension, blood in stools and inability to feed for longer durations thereby further affecting growth. In the past such babies (after birth) were not fed for days together which compromised their growth even further. It is not clear whether continuing to withhold feeds for prolonged duration will prevent NEC but lead to growth faltering and initiating feeds early will potentiate NEC with further compromised growth and increased morbidity. There are no randomized trials on feeding strategies in this group of neonates and hence the investigators planned to carry out this study on comparison of early versus delayed initiation of feeding in preterm SGA infants with AREDF.


Eligibility criteria: Inclusion Criteria:

1. Preterm neonates below 35 weeks gestation born at the study center(s)
2. Small for gestational age (SGA) ie weight \< 10th centile for gestation
3. Absent or reverse end diastolic flow (AREDF) in umbilical artery

Exclusion Criteria:

1. Babies with major congenital malformations.
2. Babies with severe asphyxia as defined by apgar score \<4 at 5 min of life with cord/within one hour of life pH\< 7.0.
3. Shock requiring pressor support at the time of randomization.
4. Babies born with gastrointestinal surgical conditions precluding enteral feeding.
5. Babies with abdominal distension, bilious or hemorrhagic aspirates or recurrent vomiting at the time of randomization.
6. Refusal to obtain consent.
7. Gestation below 26 weeks.
8. Hydrops fetalis.

Primary outcomes:
measure: Days to achieve full feeds defined as 150mL/kg
timeFrame: upto 12 weeks (84 days)
Secondary outcomes:
measure: Days to regain birth weight
timeFrame: upto 16 weeks (112 days)
measure: Feed intolerance
timeFrame: 12 weeks (84 days)
measure: Duration of stay
timeFrame: 12 - 16 weeks (84 - 112 days)
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Dr Sushma
state: Delhi
Study officials:
affiliation: All India Institute of Medical Sciences
name: Dr Sushma Nangia, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: