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

NCT01367015 | Completed DMC

• 1 other identifier: A-20/ April 2006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Preterm; SGA; AREDF; Early feeding; Late feeding; Feed intolerance; Necrotizing enterocolitis; Days to achieve Full Feeds defined as 150 mL/kg

Outcome Measures

Primary Outcomes (1)

• Days to achieve full feeds defined as 150mL/kg

  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

  upto 12 weeks (84 days)

Secondary Outcomes (3)

• Days to regain birth weight

  upto 16 weeks (112 days)

• Feed intolerance

  12 weeks (84 days)

• Duration of stay

  12 - 16 weeks (84 - 112 days)

Study Arms (2)

Early Feeding

EXPERIMENTAL

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.

Other: Early Feeding

Late feeding

ACTIVE COMPARATOR

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

Other: Late Feeding

Interventions

Early Feeding OTHER

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

Early Feeding

Late Feeding 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

Late feeding

Eligibility Criteria

• Age: 48 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Babies with major congenital malformations.
• 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.
• Shock requiring pressor support at the time of randomization.
• Babies born with gastrointestinal surgical conditions precluding enteral feeding.
• Babies with abdominal distension, bilious or hemorrhagic aspirates or recurrent vomiting at the time of randomization.
• Refusal to obtain consent.
• Gestation below 26 weeks.
• Hydrops fetalis.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead
• Sir Ganga Ram Hospital: collaborator
• Maulana Azad Medical College: collaborator
• Vardhman Mahavir Medical College And Safdarjung Hospital: collaborator
• Fernandez Hospital: collaborator

Study Sites (1)

Dr Sushma

New Delhi, National Capital Territory of Delhi, 110029, India

Location

MeSH Terms

Conditions

Premature Birth; Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Dr Sushma Nangia, MBBS, MD

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: June 6, 2011
• Study Start: April 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: March 1, 2008
• Last Updated: June 6, 2011

Record last verified: 2006-04

Locations

IN (1)