Very Preterm Maturity of InfantETEFVsCEFNCT06076460
Early Total Enteral Feeding Versus Convention Enteral Feeding in Preterm Infants 27-32 Weeks of Gestation
A study testing Early Total Enteral Feeding and Conventional Enteral Feeding in people with Very Preterm Maturity of Infant and Enteral Feeding Intolerance, run by Lady Hardinge Medical College at 1 site in India.
Trial summary
The objective of the study is to compare the time of attainment of full enteral feeds in preterm neonates between 27-32 weeks of gestation started on early total enteral feeding (ETEF) with those started on conventional enteral feeding (CEF). Read more about this study
- Who is it for?
- Ages Up to 1 hourHealthy volunteers can take part
- Conditions the study is for
- Very Preterm Maturity of Infant, Enteral Feeding Intolerance
- What is being tested?
- Early Total Enteral Feeding and Conventional Enteral Feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteIndia
- Study dates
- 11 Mar 2022to 10 Jan 2024
- 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 Up to 1 hour
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm neonate with gestational age of 27-32 weeks
Who cannot join
- Antenatally diagnosed GI malformation
- Baby born with absence or reversal of end diastolic flow on antenatal umbilical artery Doppler.
- Presence of major congenital anomalies at birth
- Need of vasopressor support at the time of randomization
- Requiring Positive Pressure Ventilation > 60 sec with APGAR score < 4 at 1 minute
Trial locations and contacts
1 site in 1 country.
India1 site
Lady Hardinge Medical College
New Delhi, National Capital Territory of Delhi, 110001
About this study
Official title: Early Total Enteral Feeding Versus Convention Enteral Feeding in Preterm Neonates Between 27 to 32 Weeks of Gestation: A Randomized Control Trial
The objective of the study is to compare the time of attainment of full enteral feeds in preterm neonates between 27-32 weeks of gestation started on early total enteral feeding (ETEF) with those started on conventional enteral feeding (CEF).
Read the detailed description
Enrolled participants will be randomly assigned to one of two study groups: 1) early total enteral feeding (ETEF) or 2) conventional enteral feeding (CEF). Regardless of study group assignment, mother's own breast milk (MOM) is the feed of choice and donor human milk is being offered if the MOM is not enough to complete the intervention as assigned
Intervention group: Feeds will be initiated with a target volume of 80 ml/kg/day starting within the first two hours after birth. Volumes will increased by 20 ml/kg/day till day 4 (total 140 ml/kg/d) and then 150ml/kg/day on day 5.
Control group: This group will receive enteral feeding volumes at a rate of 20 ml/kg/day starting within the first two hours after birth and rest of the daily requirement as Total parenteral nutrition. Volumes will be increased by 20 ml/kg/day till day 3 and thereafter by 30 ml/kg/d till 150ml/kg/day on day 6.
- Being tested
- Early Total Enteral Feeding, Conventional Enteral Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Total Enteral FeedingOther
This group will receive enteral feeding volumes at a rate of 80 ml/kg/day starting within the first two hours after birth. Volumes will increased by 20 ml/kg/day till day 4 (total 140 ml/kg/d) and then 150ml/kg/day on day 5.
Conventional Enteral FeedingOther
This group will receive enteral feeding volumes at a rate of 20 ml/kg/day starting within the first two hours after birth and rest of the daily requirement as Total parenteral nutrition. Volumes will be increased by 20 ml/kg/day till day 3 and thereafter by 30 ml/kg/d till 150ml/kg/day on day 6.
| Study group | Role | What they receive |
|---|---|---|
| Early Total Enteral Feeding | Experimental | Mom's milk or donor milk at 80 ml/kg/day after randomization within the first 2 hours Receives: Other: Early Total Enteral Feeding |
| Conventional Enteral Feeding | Active comparator | Mom's milk or donor milk at 20 ml/kg/day and rest of the requirement as Total parenteral nutrition after randomization within the first 2 hours. Receives: Other: Conventional Enteral Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of attainment of full enteral feeds (150ml/kg/day) during the first 28 days after birth
Days to attain full feeds during the first 28 days after birth
Measured: Birth to 28 days
Secondary outcomes (8)
Number of episodes of feeding intolerance
Feed intolerance will be defined as any one or more of the following a) Vomiting 3 or more in any 24 hour period, b) Any episode of blood stained or bilious vomiting, c) Abdominal girth(AG) increase >2 cm (with pre-feed aspirate >25%), abdominal wall erythema or tenderness, gross or occult blood in stools
Measured: From Randomization till 28 days after birth
Incidence of Necrotising Enterocolitis
Diagnosis of necrotizing enterocolitis any stage
Measured: From Randomization till 28 days after birth
Incidence of Sepsis
Sepsis will be defined as any one of the following in a symptomatic neonate a) Culture positive sepsis b) Sepsis screen positive, c) Strong clinical suspicion such as sclerema, shock or clinical deterioration on supportive therapy which warrants initiation of antibiotics (clinician decision)
Measured: From randomization till 28 days after birth
Total duration of intravenous fluid usage
Duration in completed days for which infant required parenteral fluid support
Measured: From randomization till 28 days after birth
Time of regaining birth weight
Duration in completed days required to regain birth weight
Measured: From randomization till 28 days after birth
Total duration of hospital stay
Duration in completed days required for treatment till discharge home or till death
Measured: From randomization till 2 months after birth
Weight gain per kg per day at 1 month of age
The weight in grams at one month of age minus the birth weight divided by the average weight (average weight =birth weight +Weight at 1 month age divided by 2) further divided by 30
Measured: Birth to 30 days
Extrauterine growth retardation (EUGR)
Weight of the infants at 36 weeks Postmenstrual age or at discharge (if earlier) below the 10th centile for age
Measured: Till 36 weeks Postmenstrual age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start11 Mar 2022
- Primary completion10 Jan 2024
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Very Preterm Maturity of InfantStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Hardinge Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sushma Nangia, M.D., Lady Hardinge Medical College
- Investigators
- Sushma Nangia, DM (NEO), Study chair, Lady Hardinge Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076460
- Sponsor's protocol ID
- LHMC/IEC/2021/03/68
- Acronym
- ETEFVsCEF
- Status last verified
- Aug 2024
- First submitted
- 31 Aug 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Walsh V, Brown JVE, Copperthwaite BR, Oddie SJ, McGuire W. Early full enteral feeding for preterm or low birth weight infants. Cochrane Database Syst Rev. 2020 Dec 27;12(12):CD013542. doi: 10.1002/14651858.CD013542.pub2.
PubMed 33368149Nangia S, Bishnoi A, Goel A, Mandal P, Tiwari S, Saili A. Early Total Enteral Feeding in Stable Very Low Birth Weight Infants: A Before and After Study. J Trop Pediatr. 2018 Feb 1;64(1):24-30. doi: 10.1093/tropej/fmx023.
PubMed 28431170
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Total Enteral Feeding Versus Convention Enteral Feeding in Preterm Neonates Between 27 to 32 Weeks of Gestation: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06076460
- Acronym / sponsor ID
- ETEFVsCEF / LHMC/IEC/2021/03/68
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Lady Hardinge Medical CollegeOther government
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 10 Oct 2023 (actual)
- 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 objective of the study is to compare the time of attainment of full enteral feeds in preterm neonates between 27-32 weeks of gestation started on early total enteral feeding (ETEF) with those started on conventional enteral feeding (CEF).
Detailed description
Enrolled participants will be randomly assigned to one of two study groups: 1) early total enteral feeding (ETEF) or 2) conventional enteral feeding (CEF). Regardless of study group assignment, mother's own breast milk (MOM) is the feed of choice and donor human milk is being offered if the MOM is not enough to complete the intervention as assigned
Intervention group: Feeds will be initiated with a target volume of 80 ml/kg/day starting within the first two hours after birth. Volumes will increased by 20 ml/kg/day till day 4 (total 140 ml/kg/d) and then 150ml/kg/day on day 5.
Control group: This group will receive enteral feeding volumes at a rate of 20 ml/kg/day starting within the first two hours after birth and rest of the daily requirement as Total parenteral nutrition. Volumes will be increased by 20 ml/kg/day till day 3 and thereafter by 30 ml/kg/d till 150ml/kg/day on day 6.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Total Enteral Feeding | Experimental | Other: Early Total Enteral FeedingMom's milk or donor milk at 80 ml/kg/day after randomization within the first 2 hours |
| Conventional Enteral Feeding | Active comparator | Other: Conventional Enteral FeedingMom's milk or donor milk at 20 ml/kg/day and rest of the requirement as Total parenteral nutrition after randomization within the first 2 hours. |
Who may qualify
- Ages
- Up to 1 hour
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm neonate with gestational age of 27-32 weeks
Key exclusion criteria (5 listed)
- Antenatally diagnosed GI malformation
- Baby born with absence or reversal of end diastolic flow on antenatal umbilical artery Doppler.
- Presence of major congenital anomalies at birth
- Need of vasopressor support at the time of randomization
- Requiring Positive Pressure Ventilation > 60 sec with APGAR score < 4 at 1 minute
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 Total Enteral FeedingThis group will receive enteral feeding volumes at a rate of 80 ml/kg/day starting within the first two hours after birth. Volumes will increased by 20 ml/kg/day till day 4 (total 140 ml/kg/d) and then 150ml/kg/day on day 5. | Other | Early Total Enteral Feeding |
| Conventional Enteral FeedingThis group will receive enteral feeding volumes at a rate of 20 ml/kg/day starting within the first two hours after birth and rest of the daily requirement as Total parenteral nutrition. Volumes will be increased by 20 ml/kg/day till day 3 and thereafter by 30 ml/kg/d till 150ml/kg/day on day 6. | Other | Conventional Enteral Feeding |
Primary outcome
Time of attainment of full enteral feeds (150ml/kg/day) during the first 28 days after birth
Time frame: Birth to 28 days
Days to attain full feeds during the first 28 days after birth
8 secondary outcomes
Number of episodes of feeding intolerance
Time frame: From Randomization till 28 days after birth
Incidence of Necrotising Enterocolitis
Time frame: From Randomization till 28 days after birth
Incidence of Sepsis
Time frame: From randomization till 28 days after birth
Total duration of intravenous fluid usage
Time frame: From randomization till 28 days after birth
Time of regaining birth weight
Time frame: From randomization till 28 days after birth
Total duration of hospital stay
Time frame: From randomization till 2 months after birth
Weight gain per kg per day at 1 month of age
Time frame: Birth to 30 days
Extrauterine growth retardation (EUGR)
Time frame: Till 36 weeks Postmenstrual age
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 13 Aug 2024.
- Background: PubMed 33368149Walsh V, Brown JVE, Copperthwaite BR, Oddie SJ, McGuire W. Early full enteral feeding for preterm or low birth weight infants. Cochrane Database Syst Rev. 2020 Dec 27;12(12):CD013542. doi: 10.1002/14651858.CD013542.pub2.
- Background: PubMed 28431170Nangia S, Bishnoi A, Goel A, Mandal P, Tiwari S, Saili A. Early Total Enteral Feeding in Stable Very Low Birth Weight Infants: A Before and After Study. J Trop Pediatr. 2018 Feb 1;64(1):24-30. doi: 10.1093/tropej/fmx023.
- Individual participant dataSharing planned: No
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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.
Sushma Nangia, DM (NEO) study chair
Lady Hardinge Medical College
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 Total Enteral Feeding and Conventional Enteral Feeding in people with Very Preterm Maturity of Infant and Enteral Feeding Intolerance, run by Lady Hardinge Medical College 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 1 inclusion and 5 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 13 Aug 2024. 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?
Time of attainment of full enteral feeds (150ml/kg/day) during the first 28 days after birth (time frame: Birth to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06076460, which also lists 2 linked publications.
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 13 Aug 2024.