Cord Blood Amino Acid ProfileNCT01140698
Amino Acid Profile in the Fetus and the Neonate
An observational study of Cord Blood Amino Acid Profile and Fetal Amino Acid Profile in Different Gestational Ages, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Up-to-date, the preterm newborn nutrition is based on human breast milk or it's imitations. However, the growth rate is known to be reduced compared to the fetal growth rate. In order to attempt a better growth rate of the preterm newborn infants it is important to evaluate the metabolic components of the fetal blood… Read more about this study
- Who is it for?
- Ages 1 day to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Cord Blood Amino Acid Profile, Fetal Amino Acid Profile in Different Gestational Ages, Infant Amino Acid Profile at Day 3 and Discharge
- What is being tested?
- Blood sample on Guthrie paper from cord blood, and day 3 of life and before discharge
- How many people
- 180 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2010to not given
- Phase
- Observational
- 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 1 day to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Term and preterm newborn infants
Who may be able to join
- All new-born infants 5 of each gestational age
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba medical center
Ramat Gan, 52621
Leah Leibovitch, MD, 972-52-6667325, leah.leibovitch@gmail.com
Leah Leibovitch, MD
About this study
Up-to-date, the preterm newborn nutrition is based on human breast milk or it's imitations. However, the growth rate is known to be reduced compared to the fetal growth rate. In order to attempt a better growth rate of the preterm newborn infants it is important to evaluate the metabolic components of the fetal blood and try to find components that might influence its growth.
Little is known of the metabolic components of the fetal blood, including amino acid profile. The aim of the study is to evaluate amino acid profile in the fetus blood in different gestational ages and compare it to post natal period.
- Conditions
- Cord Blood Amino Acid Profile, Fetal Amino Acid Profile in Different Gestational Ages, Infant Amino Acid Profile at Day 3 and Discharge
- Being tested
- Blood sample on Guthrie paper from cord blood, and day 3 of life and before discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample on Guthrie paper from cord blood, and day 3 of life and before dischargeOther
Mass spectroscopy on the blood sample that are taken as routine for the national inborn errors survey
| Study group | Role | What they receive |
|---|---|---|
| Term and preterm newborn infants | 5 infants of each gestational age of 24-42 weeks Receives: Other: Blood sample on Guthrie paper from cord blood, and day 3 of life and before discharge |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cord Blood Amino Acid ProfileStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140698
- Sponsor's protocol ID
- SHEBA-10-7895-LL-SMC
- Status last verified
- Jun 2010
- First submitted
- 8 Jun 2010
- Last updated
- 9 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amino Acid Profile in the Fetus and the Neonate
- ClinicalTrials.gov ID
- NCT01140698
- Acronym / sponsor ID
- SHEBA-10-7895-LL-SMC
- Conditions
- Cord Blood Amino Acid Profile, Fetal Amino Acid Profile in Different Gestational Ages, Infant Amino Acid Profile at Day 3 and Discharge
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jul 2010
- First posted
- 9 Jun 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.
Up-to-date, the preterm newborn nutrition is based on human breast milk or it's imitations. However, the growth rate is known to be reduced compared to the fetal growth rate. In order to attempt a better growth rate of the preterm newborn infants it is important to evaluate the metabolic components of the fetal blood and try to find components that might influence its growth.
Little is known of the metabolic components of the fetal blood, including amino acid profile. The aim of the study is to evaluate amino acid profile in the fetus blood in different gestational ages and compare it to post natal period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Term and preterm newborn infants | – | Other: Blood sample on Guthrie paper from cord blood, and day 3 of life and before discharge5 infants of each gestational age of 24-42 weeks |
Who may qualify
- Ages
- 1 day to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Term and preterm newborn infants
Key inclusion criteria (1 listed)
- All new-born infants 5 of each gestational age
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Blood sample on Guthrie paper from cord blood, and day 3 of life and before dischargeMass spectroscopy on the blood sample that are taken as routine for the national inborn errors survey | Other | Term and preterm newborn infants |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2010.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cord Blood Amino Acid Profile and Fetal Amino Acid Profile in Different Gestational Ages, run by Sheba Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 9 Jun 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leah Leibovitch, MD (972-52-6667325, leah.leibovitch@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 9 Jun 2010.