Prematurity of Fetus, Postnatal Growth Disorder
Conditions
Keywords
Preterm, SGA, AREDF, Early feeding, Late feeding, Feed intolerance, Necrotizing enterocolitis, Days to achieve Full Feeds defined as 150 mL/kg
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.
Interventions
OTHEREarly Feeding
Feeding with expressed breast milk @ 8ml/kg/day for 48 hrs after randomization at 60+/-12 hrs of life
OTHERLate Feeding
Nil per oral for another 48 hrs after randomization at 60+/-12 hrs of life followed by Feeding with expressed breast milk @ 8ml/kg/day for 48 hrs
Sponsors
Sir Ganga Ram Hospital
Maulana Azad Medical College
Vardhman Mahavir Medical College And Safdarjung Hospital
Fernandez Hospital
All India Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
48 Hours to 72 Hours
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days to achieve full feeds defined as 150mL/kg | upto 12 weeks (84 days) | First day of the three days when full enteral feeding of 150 ml/kg has been achieved and sustained as recorded from the nursing chart of the neonate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days to regain birth weight | upto 16 weeks (112 days) | After the initial fall in weight the first day when birth weight is regained or crossed and the value remains above the birth weight for subsequent 2 days will be recorded as day of life birth weight has been regained. |
| Feed intolerance | 12 weeks (84 days) | Feed intolerance was measured as number of episodes of any of the following symptoms per infant till he/she reached full feeds of 150ml/kg and sustained it for 2 days. * bilious or hemorrhagic aspirates( irrespective of the volume), * vomiting ( \>2 times in 12 hours duration) and * clear or milky aspirate \>50% of the previous feed volume necessitating feed stoppage for 24 hours |
| Duration of stay | 12 - 16 weeks (84 - 112 days) | This was taken to be the interval between birth and the day the newborn was discharged home. |
Countries
India
Outcome results
None listed