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

Prematurity of Fetus Clinical Trial

— AREDF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01367015
• Other study ID #: A-20/ April 2006
• Status: Completed
• Phase: N/A
• First received: June 1, 2011
• Last updated: June 3, 2011
• Start date: April 2006
• Est. completion date: March 2008

Study information

• Verified date: April 2006
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 72 Hours

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Growth Disorders
• Postnatal Growth Disorder
• Prematurity of Fetus

Intervention

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

Locations

Country	Name	City	State
India	Dr Sushma	New Delhi	Delhi

Sponsors (5)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi	Fernandez Hospital, Maulana Azad Medical College, Sir Ganga Ram Hospital, Vardhman Mahavir Medical College And Safdarjung Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Days to regain birth weight	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.	upto 16 weeks (112 days)	No
Secondary	Feed intolerance	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	12 weeks (84 days)	No
Secondary	Duration of stay	This was taken to be the interval between birth and the day the newborn was discharged home.	12 - 16 weeks (84 - 112 days)	No