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

NCT ID: NCT01759615

Last Updated: 2013-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-04-30

Brief Summary

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.

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.

Conditions

Time for Achievement of Full Feeds

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Early Enteral feeding

Intervention Type: OTHER

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

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

Group Type: ACTIVE_COMPARATOR

Late enteral 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 Enteral feeding

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

Intervention Type: 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

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: 60 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

All India Institute of Medical Sciences

OTHER

Sponsor Role: collaborator

Lady Hardinge Medical College

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sushma Nangia, M.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sushma Nangia, MD, DM

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Medical Sciences

Other Identifiers

AIIMS/06/AREDF

Identifier Type: -

Identifier Source: org_study_id