Nutrition of Preterm InfantsNCT02187978
Early Total Enteral Feeding Versus Conventional Enteral Feeding in Stable Very Low Birth Weight Infants
A study testing Early total enteral feeding (ETEF) and Conventional enteral feeding (CEF) in people with Nutrition of Preterm Infants, run by Lady Hardinge Medical College at 1 site in India.
Trial summary
The purpose of this study is to compare the effect of early total oral feeding versus conventional oral feeding in stable VLBW infants. In current clinical practice, the introduction of oral feeds for VLBW infants is often preceded by a period of fasting or minimal feeding because of fear of necrotizing enterocolitis… Read more about this study
- Who is it for?
- Ages 30 minutes to 120 hours
- Conditions the study is for
- Nutrition of Preterm Infants
- What is being tested?
- Early total enteral feeding (ETEF) and Conventional enteral feeding (CEF)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2014to Jul 2015
- 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 30 minutes to 120 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with gestational age between 28-34 weeks \& hemodynamically stable preterm VLBW neonates (B Wt. 1000-1499g) defined as
- No asphyxia(not required resuscitation beyond initial steps)
- No significant respiratory distress at randomization (Not requiring respiratory support)
- No clinical evidence of shock at the time of randomization (not requiring vasopressor support)
Who cannot join
- Major Congenital malformation
- Refusal of consent
- AREDF in utero
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: Comparison of Early Total Enteral Feeding (ETEF) Versus Conventional Enteral Feeding (CEF) in Stable Very Low Birth Weight (VLBW) Infants - A Randomized Controlled Trial
The purpose of this study is to compare the effect of early total oral feeding versus conventional oral feeding in stable VLBW infants. In current clinical practice, the introduction of oral feeds for VLBW infants is often preceded by a period of fasting or minimal feeding because of fear of necrotizing enterocolitis (NEC). However, this may be associated with potential disadvantages and increased infectious and metabolic complications related to prolonged fasting and use of parenteral nutrition. The studies conducted till date have shown better outcomes and improved postnatal growth with early initiation and fast advancements of feeds. It is still unclear whether stable VLBW babies can tolerate total oral feeds on day 1 of life. No such study has been conducted on early total oral feeding but observational work in our unit has shown it to be safe without any increased incidence of feed intolerance or NEC. In view of the uncertainties regarding feeding protocols in VLBW infants all over the world, the investigators decided to assess the effect of early total enteral feeding in stable VLBW infants.
Read the detailed description
Preterm VLBW infants often have negligible intrauterine reserves of nutrition along with a host of medical conditions postbirth including respiratory distress syndrome, hypoxia, hypotension, acidosis, infection and surgery. These conditions increase the metabolic energy requirements and nutrient needs of preterm babies. They require more specialised nutrition because of their faster growth rates; to correct the growth faltering post birth and to attain appropriate weight gain. Delayed postnatal growth due to inappropriate nutrition in early period leads to long term cognitive impairment and decreased school performance. Additional impediments to growth are high degree of biochemical and physiological immaturity of gastro intestinal tract with an immature immune system.
In current clinical practice, the introduction of progressive enteral feeds for preterm VLBW infants is often preceded by a period of enteral fasting or minimal enteral nutrition to decrease the incidence of NEC. However, there may also be potential disadvantages associated with delayed introduction of progressive enteral feeds. Gastrointestinal hormone secretion and motility is stimulated by enteral milk and hence delayed enteral feeding could diminish the functional adaptation of the gastrointestinal tract. In addition, 'starving' the gut may be harmful increasing susceptibility to infection due to impaired barrier function by intestinal epithelium. Parenteral nutrition (PN), though having an important role in early stabilization by allowing early calorie intake and preventing catabolism, is associated with significant risks of infectious and metabolic complications thereby increasing mortality and morbidity, prolonging hospital stay, and adversely affecting growth and development. As per recent literature reviews, enteral feeding has many advantages including appropriate intake of most nutrients. It also promotes growth and development of the gut and reduces the risk of infection. It is therefore important to establish enteral feeding as early as is safely possible. It has been argued that the risk of NEC should not be considered in isolation of these other potential clinical outcomes when determining feeding policies and practices for VLBW infants. A systematically conducted, randomized controlled trial is necessary to prove or refute the benefits of early total enteral feeding and nutrition. Hence the purpose of this prospective randomized controlled trial is to compare the benefits of early total enteral feeding over conventional enteral feeding in terms of attainment of full feeds, incidence of sepsis \& NEC and duration of hospital stay.
- Conditions
- Nutrition of Preterm Infants
- Being tested
- Early total enteral feeding (ETEF), Conventional enteral feeding (CEF)
- Keywords
- Early total enteral feeding (ETEF), Conventional enteral feeding (CEF), VLBW infants, NEC, Preterm infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early total enteral feeding (ETEF)Other
In ETEF Group total required volume of fluid will be administered as oral feeds and no intravenous fluid will be given. Feeds will be started at 80 mL/kg and increased till 150ml/kg is attained.
Conventional enteral feeding (CEF)Other
CEF Group will receive some feed and some Intravenous fluids. Feeds will be slowly increased from 20 mL/kg on day 1 till full feeds 150ml/kg is attained on day 6 of life.
| Study group | Role | What they receive |
|---|---|---|
| Early total enteral feeding (ETEF) | Experimental | Feeding will be initiated on D1 with 80ml/kg/day of expressed breast milk or LBW formula milk.
No intravenous fluid will be provided. Feeds will be advanced till 150ml/kg/day is attained. Receives: Other: Early total enteral feeding (ETEF) |
| Conventional enteral feeding (CEF) | Active comparator | Feeding will be initiated on D1of life with 20ml/kg of expressed breast milk or LBW formula milk.
Remaining requirement as intravenous fluids. Feeds advanced by 20ml/kg/day for next 2 days and then 30ml/kg/day for the next three days until 150ml/kg/day is reached. Receives: Other: Conventional enteral feeding (CEF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day of attaining 150mL/Kg of enteral feeds
Full enteral feeds are defined as oral feeds at 150ml/Kg and sustaining it for 24 hrs
Measured: Till 45 days of age
Secondary outcomes (1)
Episodes of feed intolerance
Feed intolerance defined as presence of 1 or more of the following
- Vomiting >3 times during any 24 hr period
- Any episode of bile/ blood stained vomiting
- Abdominal girth (AG) increase > 2cm between feeds with pre feed gastric aspirate > 25% of pre feed volume (milk) or any amount hgic/bilious
- Abdominal wall erythema
- Gross blood in stools
Measured: Till 30 days of age or discharge whichever is earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition of Preterm InfantsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 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, MD,DM, Principal investigator, Lady Hardinge Medical College & Kalawati Saran Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187978
- Sponsor's protocol ID
- LHMC/098/2012/ETEF
- Status last verified
- Sep 2015
- First submitted
- 7 Jul 2014
- Last updated
- 29 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Total Enteral Feeding (ETEF) Versus Conventional Enteral Feeding (CEF) in Stable Very Low Birth Weight (VLBW) Infants - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02187978
- Acronym / sponsor ID
- LHMC/098/2012/ETEF
- Conditions
- Nutrition of Preterm Infants
- Keywords
- Early total enteral feeding (ETEF), Conventional enteral feeding (CEF), VLBW infants, NEC, Preterm infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Lady Hardinge Medical CollegeOther government
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 11 Jul 2014 (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 this study is to compare the effect of early total oral feeding versus conventional oral feeding in stable VLBW infants. In current clinical practice, the introduction of oral feeds for VLBW infants is often preceded by a period of fasting or minimal feeding because of fear of necrotizing enterocolitis (NEC). However, this may be associated with potential disadvantages and increased infectious and metabolic complications related to prolonged fasting and use of parenteral nutrition. The studies conducted till date have shown better outcomes and improved postnatal growth with early initiation and fast advancements of feeds. It is still unclear whether stable VLBW babies can tolerate total oral feeds on day 1 of life. No such study has been conducted on early total oral feeding but observational work in our unit has shown it to be safe without any increased incidence of feed intolerance or NEC. In view of the uncertainties regarding feeding protocols in VLBW infants all over the world, the investigators decided to assess the effect of early total enteral feeding in stable VLBW infants.
Detailed description
Preterm VLBW infants often have negligible intrauterine reserves of nutrition along with a host of medical conditions postbirth including respiratory distress syndrome, hypoxia, hypotension, acidosis, infection and surgery. These conditions increase the metabolic energy requirements and nutrient needs of preterm babies. They require more specialised nutrition because of their faster growth rates; to correct the growth faltering post birth and to attain appropriate weight gain. Delayed postnatal growth due to inappropriate nutrition in early period leads to long term cognitive impairment and decreased school performance. Additional impediments to growth are high degree of biochemical and physiological immaturity of gastro intestinal tract with an immature immune system.
In current clinical practice, the introduction of progressive enteral feeds for preterm VLBW infants is often preceded by a period of enteral fasting or minimal enteral nutrition to decrease the incidence of NEC. However, there may also be potential disadvantages associated with delayed introduction of progressive enteral feeds. Gastrointestinal hormone secretion and motility is stimulated by enteral milk and hence delayed enteral feeding could diminish the functional adaptation of the gastrointestinal tract. In addition, 'starving' the gut may be harmful increasing susceptibility to infection due to impaired barrier function by intestinal epithelium. Parenteral nutrition (PN), though having an important role in early stabilization by allowing early calorie intake and preventing catabolism, is associated with significant risks of infectious and metabolic complications thereby increasing mortality and morbidity, prolonging hospital stay, and adversely affecting growth and development. As per recent literature reviews, enteral feeding has many advantages including appropriate intake of most nutrients. It also promotes growth and development of the gut and reduces the risk of infection. It is therefore important to establish enteral feeding as early as is safely possible. It has been argued that the risk of NEC should not be considered in isolation of these other potential clinical outcomes when determining feeding policies and practices for VLBW infants. A systematically conducted, randomized controlled trial is necessary to prove or refute the benefits of early total enteral feeding and nutrition. Hence the purpose of this prospective randomized controlled trial is to compare the benefits of early total enteral feeding over conventional enteral feeding in terms of attainment of full feeds, incidence of sepsis \& NEC and duration of hospital stay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early total enteral feeding (ETEF) | Experimental | Other: Early total enteral feeding (ETEF)Feeding will be initiated on D1 with 80ml/kg/day of expressed breast milk or LBW formula milk. No intravenous fluid will be provided. Feeds will be advanced till 150ml/kg/day is attained. |
| Conventional enteral feeding (CEF) | Active comparator | Other: Conventional enteral feeding (CEF)Feeding will be initiated on D1of life with 20ml/kg of expressed breast milk or LBW formula milk. Remaining requirement as intravenous fluids. Feeds advanced by 20ml/kg/day for next 2 days and then 30ml/kg/day for the next three days until 150ml/kg/day is reached. |
Who may qualify
- Ages
- 30 minutes to 120 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants with gestational age between 28-34 weeks \& hemodynamically stable preterm VLBW neonates (B Wt. 1000-1499g) defined as
- No asphyxia(not required resuscitation beyond initial steps)
- No significant respiratory distress at randomization (Not requiring respiratory support)
- No clinical evidence of shock at the time of randomization (not requiring vasopressor support)
Key exclusion criteria (3 listed)
- Major Congenital malformation
- Refusal of consent
- AREDF in utero
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 feeding (ETEF)In ETEF Group total required volume of fluid will be administered as oral feeds and no intravenous fluid will be given. Feeds will be started at 80 mL/kg and increased till 150ml/kg is attained. | Other | Early total enteral feeding (ETEF) |
| Conventional enteral feeding (CEF)CEF Group will receive some feed and some Intravenous fluids. Feeds will be slowly increased from 20 mL/kg on day 1 till full feeds 150ml/kg is attained on day 6 of life. | Other | Conventional enteral feeding (CEF) |
Primary outcome
Day of attaining 150mL/Kg of enteral feeds
Time frame: Till 45 days of age
Full enteral feeds are defined as oral feeds at 150ml/Kg and sustaining it for 24 hrs
1 secondary outcome
Episodes of feed intolerance
Time frame: Till 30 days of age or discharge whichever is earlier
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 29 Sep 2015.
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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, MD,DM principal investigator
Lady Hardinge Medical College & Kalawati Saran Children's Hospital
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 (ETEF) and Conventional enteral feeding (CEF) in people with Nutrition of Preterm Infants, 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 4 inclusion and 3 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 29 Sep 2015. 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?
Day of attaining 150mL/Kg of enteral feeds (time frame: Till 45 days of age). 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 29 Sep 2015.