Prematurity of FetusAREDFNCT01367015
Early Versus Late Initiation of Feeding in Premature Growth Restricted Newborns With Absent or Reversed End Diastolic Flow On Umbilical Artery Doppler (AREDF)
A study testing Early Feeding and Late Feeding in people with Prematurity of Fetus and Postnatal Growth Disorder, run by All India Institute of Medical Sciences at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 48 to 72 hours
- Conditions the study is for
- Prematurity of Fetus, Postnatal Growth Disorder
- What is being tested?
- Early Feeding and Late Feeding
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2006to Mar 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Early Feeding, Late Feeding
- Keywords
- Preterm, SGA, AREDF, Early feeding, Late feeding, Feed intolerance, Necrotizing enterocolitis, Days to achieve Full Feeds defined as 150 mL/kg
- Medical subject headings
- Premature Birth, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early FeedingOther
Feeding with expressed breast milk @ 8ml/kg/day for 48 hrs after randomization at 60+/-12 hrs of life
Late FeedingOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Late Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: upto 12 weeks (84 days)
Secondary outcomes (3)
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.
Measured: upto 16 weeks (112 days)
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
Measured: 12 weeks (84 days)
Duration of stay
This was taken to be the interval between birth and the day the newborn was discharged home.
Measured: 12 - 16 weeks (84 - 112 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startApr 2006
- Primary completionJan 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prematurity of FetusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Sir Ganga Ram Hospital, Maulana Azad Medical College, Vardhman Mahavir Medical College And Safdarjung Hospital, Fernandez Hospital
- Investigators
- Dr Sushma Nangia, MBBS, MD, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367015
- Sponsor's protocol ID
- A-20/ April 2006
- Acronym
- AREDF
- Status last verified
- Apr 2006
- First submitted
- 1 Jun 2011
- Last updated
- 6 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01367015
- Acronym / sponsor ID
- AREDF / A-20/ April 2006
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Collaborators
- Sir Ganga Ram Hospital, Maulana Azad Medical College, Vardhman Mahavir Medical College And Safdarjung Hospital, Fernandez Hospital
- Study start
- Apr 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 6 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Feeding | Experimental | Other: Early FeedingEarly 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. |
| Late feeding | Active comparator | Other: Late FeedingLate 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 |
Who may qualify
- Ages
- 48 to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early FeedingFeeding with expressed breast milk @ 8ml/kg/day for 48 hrs after randomization at 60+/-12 hrs of life | Other | Early Feeding |
| Late FeedingNil 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 | Other | Late feeding |
Primary outcome
Days to achieve full feeds defined as 150mL/kg
Time frame: upto 12 weeks (84 days)
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
3 secondary outcomes
Days to regain birth weight
Time frame: upto 16 weeks (112 days)
Feed intolerance
Time frame: 12 weeks (84 days)
Duration of stay
Time frame: 12 - 16 weeks (84 - 112 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Sushma Nangia, MBBS, MD principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Feeding and Late Feeding in people with Prematurity of Fetus and Postnatal Growth Disorder, run by All India Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days to achieve full feeds defined as 150mL/kg (time frame: upto 12 weeks (84 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2011.