Weight Gain PretermEarly Phase 1SPNNCT01217164
Strategy to Minimize In-hospital Malnutrition in Premature Babies
A Early Phase 1 study of Weight Gain Preterm, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.
Trial summary
Adequate nutrition is important for preventing malnutrition in the postnatal period and thus optimize growth and development of children born prematurely. To avoid malnutrition is recommended to provide nutrients necessary for a growth rate similar to the intrauterine life. Read more about this study
- Who is it for?
- Ages Up to 43 weeksHealthy volunteers can take part
- Conditions the study is for
- Weight Gain Preterm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2008to Jun 2010
- Phase
- Early Phase 1
- 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 43 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All very low birth weight infant after written consent of those responsible
Who cannot join
- congenital malformations, genetic syndromes and death
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Jose Luiz Muniz Bandeira Duarte
Rio de Janeiro, Rio de Janeiro, 22793-266
About this study
Adequate nutrition is important for preventing malnutrition in the postnatal period and thus optimize growth and development of children born prematurely. To avoid malnutrition is recommended to provide nutrients necessary for a growth rate similar to the intrauterine life.
For nearly one decade studying how to minimize in-hospital malnutrition in children born prematurely, especially with gestational age less than 32 weeks or with birth weight below 1,500 g, called newborn very low birth weight (VLBW).
Read more
Embleton et al.demonstrated that with the current nutritional recommendations (protein between 3.0 and 3.8 g / kg / day), the VLBW had malnutrition caused by protein and calorie cumulative deficit.
Poor nutrition in the neonatal period can impair growth and neuromotor and cognitive development after hospital discharge.
The investigators hypothesis is that VLBW subjected to aggressive nutrition with protein-calorie high from birth until discharge, would present higher weight gain than the VLBW infants who received routine diet of service, without producing adverse effects.
Read the detailed description
The study used newborn with weight less than or equal to 1,500, at the University Hospital Pedro Ernesto (HUPE) State University of Rio de Janeiro. Were defined as exclusion criteria congenital malformations, genetic syndromes and death of the patient before inclusion in the study. All children included in the study after written consent of those responsible, received aggressive parenteral nutrition immediately after birth and minimal enteral feeding in the first or second day of life. When the volume of enteral diet reached the value equal to or greater than 100 ml / kg / day was suspended intravenous hydration or parenteral nutrition. The increase of enteral nutrition was conducted in compliance with the gradual increase of 20 ml / kg / day, according the acceptance of VLBW.The clinical trial was randomized into two types of calorie intake in the diet. Newborn exposed group (EG) received enteral diet with 4.5 g / kg / day of protein and 160cal/Kg/dia, and in the control group (CG) was used usual diet with caloric intake from 3.5 to 4 g / kg / day of protein and 120-140 kcal / kg / day. The osmolality of the diet has not changed, there was an increase in the volume to achieve the desired protein-caloric. We used two types of nutrition: 1) raw milk milked exclusively at the bedside of VLBW (without fortifying additive); 2) milk formula for premature exclusive. The type of feed was considered as exclusive breastfeeding or exclusive formula for premature when there were more than 80% predominance of one type of food. The food was offered initially by orogastric catheter until the child reaches maturity to be fed by cup and / or suction.
The assessment was initiated when enteral feeding reached a volume exceeding 100 ml / kg / day and was suspended concomitant intravenous infusion or nutrition parenteral total (NPT) solution, and completed at discharge or at 43 weeks corrected gestational age, or in case of death or shutdown of the project requested by those responsible.
The calculation of caloric intake and water was daily, were presumed to breast milk values of 1.5 g of protein and 70 calorias/100 ml and in milk formula for premature infants used are listed values of 2.3 g of protein and 80 calories per 100ml.The outcome measure will be assessed when children have completed 43 weeks of corrected gestational age.
The sample size calculation assuming risk of 5%, 80% power and prevalence of 50% resulted in 60 newborn. Statistical analysis were measured average rates of weight and gestational age at birth and at discharge, the average corrected age at discharge, the rate of SGA VLBW; daily weight gain during the total days of hospitalization, the real weight gain during the period between the day of recovery of birth weight and hospital discharge. Was also calculated the difference between Z score of hospital discharge and birth for weight, length and head circumference.
Statistical calculations were performed: Ficher exact test and / or odds ratio (OR) for categorical variables, ANOVA or Kruskal-Wallis test for continuous variables. Was considered when p <0.05 as statistically significant.
- Conditions
- Weight Gain Preterm
- Being tested
- no intervention
- Keywords
- nutrition, very low birth weight, premature
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionDietary supplement
Also called Feeding preterm, Very low birth weight, weight gain, neurodevelopment
received enteral diet with 4.5 g / kg / day of protein and 160cal/Kg/dia
| Study group | Role | What they receive |
|---|---|---|
| higher protein | No intervention | Not described Receives: Dietary Supplement: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total of 64 children was followed from birth until discharge or death. The main outcome measured was weight gain during hospitalization or up to a maximum of 43 weeks gestational age when the child remained hospitalized
The results measured were: 1- the real gain in weight (weight gain during hospitalization days divided by the number of days between birth weight recovery until discharge day or time he turned 43 weeks corrected gestational age). 2 - The weight gain during hospitalization (weight gain during hospitalization divided by the number of days between the day of birth until the day of discharge).
Measured: The cutoff point for the measurement of weight was discharged or until 43 weeks corrected gestational age if prolonged hospitalization.
Secondary outcomes (1)
The difference between score Z (birth weight) and score Z (weight during discharge).
Measurements of the Z score corresponding to the birth weight and weight were discharged through the growth curve of the WHO (2006)
Measured: The cutoff point for the measurement of weight was discharged or until 43 weeks corrected gestational age if prolonged hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startOct 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight Gain PretermStudies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Pedro Ernesto
- Sponsor type
- University, hospital or other
- Investigators
- Jose L Duarte, Principal investigator, State University of Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217164
- Sponsor's protocol ID
- DUARTEJLMB-001
- Acronym
- SPN
- Status last verified
- Oct 2008
- First submitted
- 27 Aug 2010
- Last updated
- 8 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ehrenkranz RA, Younes N, Lemons JA, Fanaroff AA, Donovan EF, Wright LL, Katsikiotis V, Tyson JE, Oh W, Shankaran S, Bauer CR, Korones SB, Stoll BJ, Stevenson DK, Papile LA. Longitudinal growth of hospitalized very low birth weight infants. Pediatrics. 1999 Aug;104(2 Pt 1):280-9. doi: 10.1542/peds.104.2.280.
PubMed 10429008
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategy to Minimize In-hospital Malnutrition in Premature Babies
- ClinicalTrials.gov ID
- NCT01217164
- Acronym / sponsor ID
- SPN / DUARTEJLMB-001
- Conditions
- Weight Gain Preterm
- Keywords
- nutrition, very low birth weight, premature
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hospital Universitario Pedro ErnestoUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 8 Oct 2010 (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.
Adequate nutrition is important for preventing malnutrition in the postnatal period and thus optimize growth and development of children born prematurely. To avoid malnutrition is recommended to provide nutrients necessary for a growth rate similar to the intrauterine life.
For nearly one decade studying how to minimize in-hospital malnutrition in children born prematurely, especially with gestational age less than 32 weeks or with birth weight below 1,500 g, called newborn very low birth weight (VLBW).
Embleton et al.demonstrated that with the current nutritional recommendations (protein between 3.0 and 3.8 g / kg / day), the VLBW had malnutrition caused by protein and calorie cumulative deficit.
Poor nutrition in the neonatal period can impair growth and neuromotor and cognitive development after hospital discharge.
The investigators hypothesis is that VLBW subjected to aggressive nutrition with protein-calorie high from birth until discharge, would present higher weight gain than the VLBW infants who received routine diet of service, without producing adverse effects.
Detailed description
The study used newborn with weight less than or equal to 1,500, at the University Hospital Pedro Ernesto (HUPE) State University of Rio de Janeiro. Were defined as exclusion criteria congenital malformations, genetic syndromes and death of the patient before inclusion in the study. All children included in the study after written consent of those responsible, received aggressive parenteral nutrition immediately after birth and minimal enteral feeding in the first or second day of life. When the volume of enteral diet reached the value equal to or greater than 100 ml / kg / day was suspended intravenous hydration or parenteral nutrition. The increase of enteral nutrition was conducted in compliance with the gradual increase of 20 ml / kg / day, according the acceptance of VLBW.The clinical trial was randomized into two types of calorie intake in the diet. Newborn exposed group (EG) received enteral diet with 4.5 g / kg / day of protein and 160cal/Kg/dia, and in the control group (CG) was used usual diet with caloric intake from 3.5 to 4 g / kg / day of protein and 120-140 kcal / kg / day. The osmolality of the diet has not changed, there was an increase in the volume to achieve the desired protein-caloric. We used two types of nutrition: 1) raw milk milked exclusively at the bedside of VLBW (without fortifying additive); 2) milk formula for premature exclusive. The type of feed was considered as exclusive breastfeeding or exclusive formula for premature when there were more than 80% predominance of one type of food. The food was offered initially by orogastric catheter until the child reaches maturity to be fed by cup and / or suction.
The assessment was initiated when enteral feeding reached a volume exceeding 100 ml / kg / day and was suspended concomitant intravenous infusion or nutrition parenteral total (NPT) solution, and completed at discharge or at 43 weeks corrected gestational age, or in case of death or shutdown of the project requested by those responsible.
The calculation of caloric intake and water was daily, were presumed to breast milk values of 1.5 g of protein and 70 calorias/100 ml and in milk formula for premature infants used are listed values of 2.3 g of protein and 80 calories per 100ml.The outcome measure will be assessed when children have completed 43 weeks of corrected gestational age.
The sample size calculation assuming risk of 5%, 80% power and prevalence of 50% resulted in 60 newborn. Statistical analysis were measured average rates of weight and gestational age at birth and at discharge, the average corrected age at discharge, the rate of SGA VLBW; daily weight gain during the total days of hospitalization, the real weight gain during the period between the day of recovery of birth weight and hospital discharge. Was also calculated the difference between Z score of hospital discharge and birth for weight, length and head circumference.
Statistical calculations were performed: Ficher exact test and / or odds ratio (OR) for categorical variables, ANOVA or Kruskal-Wallis test for continuous variables. Was considered when p <0.05 as statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| higher protein | No intervention | Dietary Supplement: no intervention |
Who may qualify
- Ages
- Up to 43 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All very low birth weight infant after written consent of those responsible
Key exclusion criteria (1 listed)
- congenital malformations, genetic syndromes and death
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 |
|---|---|---|
| no interventionAlso: Feeding preterm, Very low birth weight, weight gain, neurodevelopmentreceived enteral diet with 4.5 g / kg / day of protein and 160cal/Kg/dia | Dietary supplement | higher protein |
Primary outcome
The total of 64 children was followed from birth until discharge or death. The main outcome measured was weight gain during hospitalization or up to a maximum of 43 weeks gestational age when the child remained hospitalized
Time frame: The cutoff point for the measurement of weight was discharged or until 43 weeks corrected gestational age if prolonged hospitalization.
The results measured were: 1- the real gain in weight (weight gain during hospitalization days divided by the number of days between birth weight recovery until discharge day or time he turned 43 weeks corrected gestational age). 2 - The weight gain during hospitalization (weight gain during hospitalization divided by the number of days between the day of birth until the day of discharge).
1 secondary outcome
The difference between score Z (birth weight) and score Z (weight during discharge).
Time frame: The cutoff point for the measurement of weight was discharged or until 43 weeks corrected gestational age if prolonged hospitalization.
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 8 Oct 2010.
- Results publication: PubMed 10429008Ehrenkranz RA, Younes N, Lemons JA, Fanaroff AA, Donovan EF, Wright LL, Katsikiotis V, Tyson JE, Oh W, Shankaran S, Bauer CR, Korones SB, Stoll BJ, Stevenson DK, Papile LA. Longitudinal growth of hospitalized very low birth weight infants. Pediatrics. 1999 Aug;104(2 Pt 1):280-9. doi: 10.1542/peds.104.2.280.
- university hospital ou state university of rio de janeiroLink provided by the sponsor.
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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.
Jose L Duarte principal investigator
State University of Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study of Weight Gain Preterm, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.
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 1 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 8 Oct 2010. 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 Brazil. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The total of 64 children was followed from birth until discharge or death. The main outcome measured was weight gain during hospitalization or up to a maximum of 43 weeks gestational age when the child remained hospitalized (time frame: The cutoff point for the measurement of weight was discharged or until 43 weeks corrected gestational age if prolonged hospitalization.). 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 NCT01217164, which also lists 1 linked publication.
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 8 Oct 2010.