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

This study has been completed.
Sponsor:
Collaborators:
Sir Ganga Ram Hospital
Maulana Azad Medical College
Vardhman Mahavir Medical College And Safdarjung Hospital
Fernandez Hospital
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01367015
First received: June 1, 2011
Last updated: June 3, 2011
Last verified: April 2006
  Purpose

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.


Condition Intervention
Prematurity of Fetus
Postnatal Growth Disorder
Other: Early Feeding
Other: Late Feeding

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Days to achieve full feeds defined as 150mL/kg [ Time Frame: upto 12 weeks (84 days) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Days to regain birth weight [ Time Frame: upto 16 weeks (112 days) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks (84 days) ] [ Designated as safety issue: No ]

    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 [ Time Frame: 12 - 16 weeks (84 - 112 days) ] [ Designated as safety issue: No ]
    This was taken to be the interval between birth and the day the newborn was discharged home.


Enrollment: 60
Study Start Date: April 2006
Study Completion Date: March 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: Early Feeding
Feeding with expressed breast milk @ 8ml/kg/day for 48 hrs after randomization at 60+/-12 hrs of life
Active Comparator: 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
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

  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367015

Locations
India
Dr Sushma
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Sir Ganga Ram Hospital
Maulana Azad Medical College
Vardhman Mahavir Medical College And Safdarjung Hospital
Fernandez Hospital
Investigators
Principal Investigator: Dr Sushma Nangia, MBBS, MD All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided

Responsible Party: Dr Sushma Nangia, All India Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT01367015     History of Changes
Other Study ID Numbers: A-20/ April 2006
Study First Received: June 1, 2011
Last Updated: June 3, 2011
Health Authority: India: Indian Council of Medical Research

Keywords provided by All India Institute of Medical Sciences, New Delhi:
Preterm
SGA
AREDF
Early feeding
Late feeding
Feed intolerance
Necrotizing enterocolitis
Days to achieve Full Feeds defined as 150 mL/kg

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014