Early Versus Late Initiation of Feeding in Preterm Newborns With Prenatal AREDF in Umbilical Artery

This study has been completed.
Sponsor:
Collaborator:
All India Institute of Medical Sciences, New Delhi
Information provided by (Responsible Party):
Sushma Nangia, M.D., Lady Hardinge Medical College
ClinicalTrials.gov Identifier:
NCT01759615
First received: December 23, 2012
Last updated: December 31, 2012
Last verified: December 2012
  Purpose

This research is being conducted in preterm newborns with 'in utero' growth restriction due to inadequate blood flow from the mother to the baby. These deprived babies adapt to the not so conducive uterine environment by certain adjustments in blood supply to internal organs thereby permitting as best as possible blood flow to brain heart etc., which are the vital organs and whose adequate functioning is required for survival. In this bargain the gut (intestines) gets poor blood supply and hence its appropriate functioning is jeopardized. In the past such babies (after birth) were not fed for days together which compromised their growth even further. Premature growth restricted' babies are at increased risk of further growth faltering if not fed in time 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 much longer duration thereby further affecting growth. This study is evaluating a feeding schedule of early versus late initiation of feeding to arrive at the best time to feed such doubly jeopardized premature growth restricted babies to avert the above mentioned consequences.

No study has been conducted in India to confirm the aforementioned fact and hence this study has been planned. The information learned from this study will help us to feed these small premature as well as growth restricted babies with AREDF better which will go a long way in the care of such preterm growth restricted newborns.


Condition Intervention
Time for Achievement of Full Feeds
Other: Early Enteral feeding
Other: Late enteral 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

Further study details as provided by Lady Hardinge Medical College:

Primary Outcome Measures:
  • Time taken to achieve full feeds [ Time Frame: in days upto six weeks ] [ 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 infant.


Secondary Outcome Measures:
  • Days to regain birth weight [ Time Frame: in days upto six weeks ] [ 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: till achievement of full feeds ] [ 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: in days upto twelve weeks ] [ 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: April 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early enteral feeding
Early enteral feeding group received minimal enteral feed (MEF) of 8 ml/kg of expressed human milk of the biologic mother for 48 hours followed by regular feeding with feed increments of 20ml/kg/day to reach 150 ml/kg.
Other: Early Enteral feeding
Feeding with expressed breast milk @ 8ml/kg/day for 48 hrs after randomization at 60+/-12 hrs of life
Active Comparator: Late enteral feeding
Late enteral feeding group was kept NPO for a period of 48 hours 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 enteral 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

Detailed Description:

Absence or reversal of end diastolic flow (AREDF) in the umbilical artery is associated with poor outcome. This is further exaggerated by the presence of intrauterine growth retardation and oligohydramnios. Elective premature delivery of such fetuses is common. AREDF leads to circulatory redistribution with decreased blood flow to the lung, intestines, kidneys, skin, and muscle, and blood diverted to the brain, myocardium and adrenals. This reduction in visceral perfusion has been associated with an increased risk of necrotising enterocolitis, cerebral haemorrhage, and neonatal morbidity. Because of concern that feedings may increase the risk of necrotizing enterocolitis, some high-risk infants (most studies on preterm AGA) have received prolonged periods of parenteral nutrition without enteral feedings. Providing trophic feedings (small volume feedings given at the same rate for at least 5 days) during this period of parenteral nutrition was developed as a strategy to enhance feeding tolerance and decrease time to reach full feedings. Whether trophic feedings result in better outcomes than initially withholding feedings or providing progressively increasing feedings can be established only in proper clinical trials.

There are no standard guidelines to feed these preterm SGA infants born to mothers with abnormal antenatal Doppler studies. Furthermore, there are no randomized trials on feeding strategies in this group of neonates and hence we planned to carry out this study on comparison of early versus delayed initiation of feeding in preterm SGA infants with AREDF.

The purpose of this study is to compare the time to reach full enteral feeds, time to regain birth weight etc. in babies who are fed carefully versus those who are not fed for the initial days. It is postulated that early gut priming may stimulate the gut to secrete certain trophic and growth factors which may make it better able to tolerate enteral feeds improving the overall growth and also reducing chances of infection.

  Eligibility

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01759615

Sponsors and Collaborators
Lady Hardinge Medical College
All India Institute of Medical Sciences, New Delhi
Investigators
Principal Investigator: Sushma Nangia, MD, DM All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided

Responsible Party: Sushma Nangia, M.D., Professor, Lady Hardinge Medical College
ClinicalTrials.gov Identifier: NCT01759615     History of Changes
Other Study ID Numbers: AIIMS/06/AREDF
Study First Received: December 23, 2012
Last Updated: December 31, 2012
Health Authority: India: Indian Council of Medical Research

Keywords provided by Lady Hardinge Medical College:
Preterm
SGA
AREDF
Early feeding
Late feeding
Feed intolerence
Necrotizing enterocolitis

ClinicalTrials.gov processed this record on July 23, 2014