Infant, Very Low Birth WeightPhase 4NCT01341236
Near Infrared Spectroscopy (NIRS) and Superior Mesenteric Artery (SMA) Doppler Patterns as Predictor of Feeding Tolerance in Very Low Birth Weight (VLBW) IntraUterine Growth Restricted (IUGR) and NON IUGR Infants
A Phase 4 study testing different nutrional regimen and comparison of different feeding regimens in people with Infant, Very Low Birth Weight and Infant Malnutrition, run by San Gerardo Hospital at 1 site in Italy.
Trial summary
This study aims at recruiting about twenty very low birth weight infants, either intrauterine growth restricted (IUGR) or NON-IUGR STRATIFICATION:Population will be stratified in two groups: IUGR infants (approximately 10 children) and NON-IUGR infants (approximately 10 children). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infant, Very Low Birth Weight, Infant Malnutrition, Feeding Disorder of Infancy or Early Childhood
- What is being tested?
- different nutrional regimen and comparison of different feeding regimens
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2011to Mar 2013
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Weight at birth ranging: 700 - 1501 grams;
- Gestational age up to 25 weeks and 6 days;
- Written informed consent from parents or guardians.
Who cannot join
- Major congenital abnormality (severe heart or cerebral disease, chromosomopathies, severe renal malformations, any malformation or disease of the gastroenteric tract)
- Significant multi-organ failure prior to trial entry (perinatal asphyxia with renal, cardiac or cerebral impairment, DIC)
- Pre-existing cutaneous disease not allowing the placement of the probe
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Splanchnic Oximetry,Doppler Flow Velocimetry in the Superior Mesenteric Artery and Feeding Tolerance in VERY LOW BIRTH WEIGHT IUGR and NON-IUGR Infants Receiving Bolus Versus Continuous Enteral Nutrition
This study aims at recruiting about twenty very low birth weight infants, either intrauterine growth restricted (IUGR) or NON-IUGR
STRATIFICATION:Population will be stratified in two groups: IUGR infants (approximately 10 children) and NON-IUGR infants (approximately 10 children).
Read more
PRIMARY ENDPOINT:To evaluate the changes in the intestinal perfusion determined by feeding in VLBW infants fed by 3 hours nasogastric nutrition (CN) or by bolus (BN).
SECONDARY ENDPOINT:
- To compare if changes in the intestinal perfusion induced by feeding are different between IUGR and NON-IUGR infants;
- To compare growth and nutritional status of the 2 groups by randomized arm.
- To evaluate if changes of intestinal perfusion and oximetry induced by feeding are related to baseline (< 72 hours of life) values of Doppler flow velocimetry and of Near Infrared Spectroscopy (NIRS). After birth, in the first 24 hours of life, and in the transitional period, between the 48th and 72nd hours of life, all infants' intestinal perfusion will be evaluated with NIRS and a doppler of the superior mesenteric artery will be executed.
- To test if changes in intestinal oximetry and perfusion can be reliable predictors of feeding intolerance (need of interruption of enteral feeding).
DESIGN: This is a randomized, non-pharmacological, single-center, cross-over study including 20 VLBW babies. Duration of the study: 24 months.
INCLUSION CRITERIA
- Weight at birth ranging: 700 - 1501 grams;
- Gestational age up to 25 weeks and 6 days;
- Written informed consent from parents or guardians
EXCLUSION CRITERIA
- Major congenital abnormality (severe heart or cerebral disease, chromosomopathies, severe renal malformations, any malformation or disease of the gastroenteric tract)
- Significant multi-organ failure prior to trial entry (perinatal asphyxia with renal, cardiac or cerebral impairment, DIC)
- Pre-existing cutaneous disease not allowing the placement of the probe
- Conditions
- Infant, Very Low Birth Weight, Infant Malnutrition, Feeding Disorder of Infancy or Early Childhood, Splanchnic Oximetry, Splanchnic Oxygenation
- Being tested
- different nutrional regimen, comparison of different feeding regimens
- Keywords
- VLBW, IUGR, NIRS, enteral nutrition, superior mesenteric artery doppler
- Medical subject headings
- Infant Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different nutrional regimenOther
compare bolus versus intermittent nutrition
comparison of different feeding regimensOther
compare intermittent versus bolus nutrition
| Study group | Role | What they receive |
|---|---|---|
| continuous nutrition | Active comparator | Not described Receives: Other: different nutrional regimen |
| bolus nutrition | Active comparator | Not described Receives: Other: comparison of different feeding regimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in the intestinal perfusion determined by feeding in VLBW infants fed by 3 hours nasogastric nutrition (CN) or by bolus (BN).
Evaluation of oximetry with splanchnic NIRS (difference of CSOR values and of rSO2s values) and perfusion with doppler of superior mesenteric artery (differences of peak sistolic and end-diastolic velocity, mean velocity, and pulsatility index) before, during ad after feeding.
Measured: 3 hours
Secondary outcomes (4)
To compare of changes in the intestinal perfusion induced by feeding are different between IUGR and NON-IUGR infants;
- To compare if changes in the intestinal perfusion induced by feeding are different between IUGR and NON-IUGR infants with NIRS (difference of CSOR values and of rSO2s values) and doppler of the superior mesenteric artery measurements (difference of peak sistolic and end-diastolic velocity, mean velocity, and pulsatility index) ;
Measured: 2 weeks; it's an average;it depends on the time necessary to achieve an enteral intake of 100 mL/Kg/die
• To compare growth and nutritional status of the 2 groups by randomized arm.
Measurements of body weight (grams), length and head circumference (cm) will be performed at predefined times: at birth, at the beginning of MEF, on the randomization day, at the achievement of full enteral feeding, at 28 days of life and at 36 weeks of gestational age
Measured: 2 months; it's an average;it depends on the time necessary to achieve the full enteral feeding and the 36th weeks of postconceptional age
• To evaluate if changes of intestinal perfusion and oximetry induced by feeding are related to baseline (< 72 hours of life) values of Doppler flow velocimetry and of NIRS.
Comparison of the values of Doppler flow velocimetry of the superior mesenteric artery and of abdominal NIRS during feeding with those registered after birth, in the first 24 hours of life, and in the transitional period.
Measured: 2 weeks
• To test if changes in intestinal oximetry and perfusion can be reliable predictors of feeding intolerance
Time necessary to achieve full enteral feeding will be recorded
Measured: 1 month; it's an average;it depends on the time necessary to achieve the full enteral feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2013
- Study completionMar 2013
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 Infant, Very Low Birth WeightStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Gerardo Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Bozzetti, San Gerardo Hospital
- Investigators
- Paolo E Tagliabue, MD, Study director, San Gerardo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341236
- Sponsor's protocol ID
- Feeding VLBW
- Status last verified
- Mar 2013
- First submitted
- 12 Apr 2011
- Last updated
- 22 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Bozzetti V, Paterlini G, De Lorenzo P, Gazzolo D, Valsecchi MG, Tagliabue PE. Impact of Continuous vs Bolus Feeding on Splanchnic Perfusion in Very Low Birth Weight Infants: A Randomized Trial. J Pediatr. 2016 Sep;176:86-92.e2. doi: 10.1016/j.jpeds.2016.05.031. Epub 2016 Jun 20.
PubMed 27339251Bozzetti V, Paterlini G, Meroni V, DeLorenzo P, Gazzolo D, Van Bel F, Visser GH, Valsecchi M, Tagliabue PE. Evaluation of splanchnic oximetry, Doppler flow velocimetry in the superior mesenteric artery and feeding tolerance in very low birth weight IUGR and non-IUGR infants receiving bolus versus continuous enteral nutrition. BMC Pediatr. 2012 Jul 24;12:106. doi: 10.1186/1471-2431-12-106.
PubMed 22828032
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Splanchnic Oximetry,Doppler Flow Velocimetry in the Superior Mesenteric Artery and Feeding Tolerance in VERY LOW BIRTH WEIGHT IUGR and NON-IUGR Infants Receiving Bolus Versus Continuous Enteral Nutrition
- ClinicalTrials.gov ID
- NCT01341236
- Acronym / sponsor ID
- Feeding VLBW
- Conditions
- Infant, Very Low Birth Weight, Infant Malnutrition, Feeding Disorder of Infancy or Early Childhood, Splanchnic Oximetry, Splanchnic Oxygenation
- Keywords
- VLBW, IUGR, NIRS, enteral nutrition, superior mesenteric artery doppler
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- San Gerardo HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 25 Apr 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.
This study aims at recruiting about twenty very low birth weight infants, either intrauterine growth restricted (IUGR) or NON-IUGR
STRATIFICATION:Population will be stratified in two groups: IUGR infants (approximately 10 children) and NON-IUGR infants (approximately 10 children).
PRIMARY ENDPOINT:To evaluate the changes in the intestinal perfusion determined by feeding in VLBW infants fed by 3 hours nasogastric nutrition (CN) or by bolus (BN).
SECONDARY ENDPOINT:
- To compare if changes in the intestinal perfusion induced by feeding are different between IUGR and NON-IUGR infants;
- To compare growth and nutritional status of the 2 groups by randomized arm.
- To evaluate if changes of intestinal perfusion and oximetry induced by feeding are related to baseline (< 72 hours of life) values of Doppler flow velocimetry and of Near Infrared Spectroscopy (NIRS). After birth, in the first 24 hours of life, and in the transitional period, between the 48th and 72nd hours of life, all infants' intestinal perfusion will be evaluated with NIRS and a doppler of the superior mesenteric artery will be executed.
- To test if changes in intestinal oximetry and perfusion can be reliable predictors of feeding intolerance (need of interruption of enteral feeding).
DESIGN: This is a randomized, non-pharmacological, single-center, cross-over study including 20 VLBW babies. Duration of the study: 24 months.
INCLUSION CRITERIA
- Weight at birth ranging: 700 - 1501 grams;
- Gestational age up to 25 weeks and 6 days;
- Written informed consent from parents or guardians
EXCLUSION CRITERIA
- Major congenital abnormality (severe heart or cerebral disease, chromosomopathies, severe renal malformations, any malformation or disease of the gastroenteric tract)
- Significant multi-organ failure prior to trial entry (perinatal asphyxia with renal, cardiac or cerebral impairment, DIC)
- Pre-existing cutaneous disease not allowing the placement of the probe
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous nutrition | Active comparator | Other: different nutrional regimen |
| bolus nutrition | Active comparator | Other: comparison of different feeding regimens |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Weight at birth ranging: 700 - 1501 grams;
- Gestational age up to 25 weeks and 6 days;
- Written informed consent from parents or guardians.
Key exclusion criteria (3 listed)
- Major congenital abnormality (severe heart or cerebral disease, chromosomopathies, severe renal malformations, any malformation or disease of the gastroenteric tract)
- Significant multi-organ failure prior to trial entry (perinatal asphyxia with renal, cardiac or cerebral impairment, DIC)
- Pre-existing cutaneous disease not allowing the placement of the probe
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 |
|---|---|---|
| different nutrional regimencompare bolus versus intermittent nutrition | Other | continuous nutrition |
| comparison of different feeding regimenscompare intermittent versus bolus nutrition | Other | bolus nutrition |
Primary outcome
changes in the intestinal perfusion determined by feeding in VLBW infants fed by 3 hours nasogastric nutrition (CN) or by bolus (BN).
Time frame: 3 hours
Evaluation of oximetry with splanchnic NIRS (difference of CSOR values and of rSO2s values) and perfusion with doppler of superior mesenteric artery (differences of peak sistolic and end-diastolic velocity, mean velocity, and pulsatility index) before, during ad after feeding.
4 secondary outcomes
To compare of changes in the intestinal perfusion induced by feeding are different between IUGR and NON-IUGR infants;
Time frame: 2 weeks; it's an average;it depends on the time necessary to achieve an enteral intake of 100 mL/Kg/die
• To compare growth and nutritional status of the 2 groups by randomized arm.
Time frame: 2 months; it's an average;it depends on the time necessary to achieve the full enteral feeding and the 36th weeks of postconceptional age
• To evaluate if changes of intestinal perfusion and oximetry induced by feeding are related to baseline (< 72 hours of life) values of Doppler flow velocimetry and of NIRS.
Time frame: 2 weeks
• To test if changes in intestinal oximetry and perfusion can be reliable predictors of feeding intolerance
Time frame: 1 month; it's an average;it depends on the time necessary to achieve the full enteral feeding
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 22 Mar 2013.
- Derived from this study: PubMed 27339251Bozzetti V, Paterlini G, De Lorenzo P, Gazzolo D, Valsecchi MG, Tagliabue PE. Impact of Continuous vs Bolus Feeding on Splanchnic Perfusion in Very Low Birth Weight Infants: A Randomized Trial. J Pediatr. 2016 Sep;176:86-92.e2. doi: 10.1016/j.jpeds.2016.05.031. Epub 2016 Jun 20.
- Derived from this study: PubMed 22828032Bozzetti V, Paterlini G, Meroni V, DeLorenzo P, Gazzolo D, Van Bel F, Visser GH, Valsecchi M, Tagliabue PE. Evaluation of splanchnic oximetry, Doppler flow velocimetry in the superior mesenteric artery and feeding tolerance in very low birth weight IUGR and non-IUGR infants receiving bolus versus continuous enteral nutrition. BMC Pediatr. 2012 Jul 24;12:106. doi: 10.1186/1471-2431-12-106.
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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.
Paolo E Tagliabue, MD study director
San Gerardo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing different nutrional regimen and comparison of different feeding regimens in people with Infant, Very Low Birth Weight and Infant Malnutrition, run by San Gerardo Hospital at 1 site in Italy.
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 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 22 Mar 2013. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
changes in the intestinal perfusion determined by feeding in VLBW infants fed by 3 hours nasogastric nutrition (CN) or by bolus (BN). (time frame: 3 hours). 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 NCT01341236, 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 22 Mar 2013.