Premature InfantNCT03100305
Amino Acids Profiles in Premature Infants Receiving Nutritional Support
An observational study of Premature Infant, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The aim of this study is to investigate the changes of amino acid metabolic profiles in different nutritional stages of preterm infants and determine the effects of nutritional intervention on the amino acid metabolic status of preterm infants. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Premature Infant
- What is being tested?
- Collection of blood and urine
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 20 Mar 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Preterm infants who experience various nutritional stages including total parenteral nutrition, partial parenteral nutrition and enteral nutrition
Who may be able to join
- Premature infants, and admitted to hospital within 24 hours after birth; Documentation of informed consent; In need of receiving parenteral nutrition after birth;
Who cannot join
- Premature infants with a parenteral nutrition period of less than 3 days; Inborn error of metabolism; Chromosomal abnormalities or multiple malformations;
Trial locations and contacts
1 site in 1 country.
China1 site
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
About this study
Official title: A Prospective Study of Amino Acids Profiles in Premature Infants Receiving Nutritional Support
The aim of this study is to investigate the changes of amino acid metabolic profiles in different nutritional stages of preterm infants and determine the effects of nutritional intervention on the amino acid metabolic status of preterm infants.
- Conditions
- Premature Infant
- Being tested
- Collection of blood and urine
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of blood and urineOther
Collection of blood and urine before nutritional support, during total parenteral nutrition, during partial parenteral nutrition and during enteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| Extremely preterm infants | Not described Receives: Other: Collection of blood and urine | |
| Very preterm infants | Not described Receives: Other: Collection of blood and urine | |
| Moderately preterm infants | Not described Receives: Other: Collection of blood and urine | |
| Late preterm infants | Not described Receives: Other: Collection of blood and urine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amino acid profiles in blood
Amino acid levels in blood
Measured: through the transition to enteral nutrition, an average of 1 month
Secondary outcomes (3)
Weight
Measured: Until the corrected gestational age is 37 weeks or discharged
Height
Measured: Until the corrected gestational age is 37 weeks or discharged
Head circumference
Measured: Until the corrected gestational age is 37 weeks or discharged
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Jan 2017
- Primary completion15 Feb 2018
- Study completion20 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- 124 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhenjuan He, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Zhenjuan He, master, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100305
- Sponsor's protocol ID
- XH-17-001
- Status last verified
- Mar 2018
- First submitted
- 21 Feb 2017
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Amino Acids Profiles in Premature Infants Receiving Nutritional Support
- ClinicalTrials.gov ID
- NCT03100305
- Acronym / sponsor ID
- XH-17-001
- Conditions
- Premature Infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 15 Feb 2018 (actual)
- Study completion
- 20 Mar 2018 (actual)
- First posted
- 4 Apr 2017 (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 aim of this study is to investigate the changes of amino acid metabolic profiles in different nutritional stages of preterm infants and determine the effects of nutritional intervention on the amino acid metabolic status of preterm infants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Extremely preterm infants | – | Other: Collection of blood and urine |
| Very preterm infants | – | Other: Collection of blood and urine |
| Moderately preterm infants | – | Other: Collection of blood and urine |
| Late preterm infants | – | Other: Collection of blood and urine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Preterm infants who experience various nutritional stages including total parenteral nutrition, partial parenteral nutrition and enteral nutrition
Key inclusion criteria (1 listed)
- Premature infants, and admitted to hospital within 24 hours after birth; Documentation of informed consent; In need of receiving parenteral nutrition after birth;
Key exclusion criteria (1 listed)
- Premature infants with a parenteral nutrition period of less than 3 days; Inborn error of metabolism; Chromosomal abnormalities or multiple malformations;
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 |
|---|---|---|
| Collection of blood and urineCollection of blood and urine before nutritional support, during total parenteral nutrition, during partial parenteral nutrition and during enteral nutrition | Other | Extremely preterm infants, Late preterm infants, Moderately preterm infants, Very preterm infants |
Primary outcome
Amino acid profiles in blood
Time frame: through the transition to enteral nutrition, an average of 1 month
Amino acid levels in blood
3 secondary outcomes
Weight
Time frame: Until the corrected gestational age is 37 weeks or discharged
Height
Time frame: Until the corrected gestational age is 37 weeks or discharged
Head circumference
Time frame: Until the corrected gestational age is 37 weeks or discharged
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 3 Apr 2018.
- 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.
Zhenjuan He, master principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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 Premature Infant, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 3 Apr 2018. 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 China. 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?
Amino acid profiles in blood (time frame: through the transition to enteral nutrition, an average of 1 month). 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 3 Apr 2018.