Early Versus Late Initiation of Feeding in Premature Growth Restricted Newborns With Absent or Reversed End Diastolic Flow On Umbilical Artery Doppler (AREDF)

NCT ID: NCT01367015

Last Updated: 2011-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2008-03-31

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.

Conditions

Prematurity of Fetus; Postnatal Growth Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Early Feeding

Early feeding group received minimal enteral feed (MEF) of 8 ml/kg of expressed human milk of the biologic mother for 48 hours after randomization followed by regular feeding with feed increments of 20ml/kg/day to reach 150 ml/kg.

Group Type: EXPERIMENTAL

Early Feeding

Intervention Type: OTHER

Feeding with expressed breast milk @ 8ml/kg/day for 48 hrs after randomization at 60+/-12 hrs of life

Late feeding

Late feeding group was kept NPO for a period of 48 hours after randomization followed by minimal enteral feed (MEF) of 8 ml/kg of expressed human milk of the biologic mother for 48 hours and thereafter received regular feeding with feed increments of 20ml/kg/day till full enteral feeds of 150 ml/kg/day were achieved

Group Type: ACTIVE_COMPARATOR

Late Feeding

Intervention Type: OTHER

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

Interventions

Early Feeding

Feeding with expressed breast milk @ 8ml/kg/day for 48 hrs after randomization at 60+/-12 hrs of life

Intervention Type: OTHER

Late 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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 48 Hours
• Maximum Eligible Age: 72 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sir Ganga Ram Hospital

OTHER

Sponsor Role: collaborator

Maulana Azad Medical College

OTHER

Sponsor Role: collaborator

Vardhman Mahavir Medical College And Safdarjung Hospital

OTHER

Sponsor Role: collaborator

Fernandez Hospital

UNKNOWN

Sponsor Role: collaborator

All India Institute of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

All India Institute of Medical Sciences

Principal Investigators

Dr Sushma Nangia, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences

Locations

Dr Sushma

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

A-20/ April 2006

Identifier Type: -

Identifier Source: org_study_id