PrematureNCT04143204
Nutrition and Growth in Very Preterm Infants
An observational study of Premature and Growth, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
This study aims to explore the relation of early nutritional intake, especially oral nutrition intake, with growth and body composition among very preterm or very low birth weight infants. Read more about this study
- Who is it for?
- Ages 1 day to 18 months
- What is being tested?
- Oral nutritional intake
- Type of treatment
- Pill or oral medicine
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 31 Oct 2022
- 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 18 months
- All sexes
- No healthy volunteers
- Child
Study population: Very preterm or very low birth weight infants in NICU
Who may be able to join
- infants born with a gestational age >=28 weeks and <32 weeks and/or a birth weight >=1000g and <1500g;
- infants admitted to neonatal intensive care unit (NICU) of Children's hospital of Fudan University within 24h after birth.
Who cannot join
- major congenital anomalies or heredity metabolic diseases;
- severe disease or abdominal surgery during hospitalization;
- death during hospitalization or discharge without medical advice;
- small for gestational age.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Early Nutritional Intake and Growth in Very Preterm or Very Low Birth Weight Infants: a Prospective Cohort Study
This study aims to explore the relation of early nutritional intake, especially oral nutrition intake, with growth and body composition among very preterm or very low birth weight infants.
Read the detailed description
As the survival of very preterm infants increases, it is important to evaluate their long-term outcomes. Nutritional intake during early life was important to the growth and development in infants, especially in preterm infants. Studies found that early nutrition exposure in preterm infants can effect scored of Griffith Mental Development Scales and body fat percentage at later life. Insulin-like growth factor-1, leptin, Ghrelin, C-Peptide are associated with fat mass in children. And accumulation of fat and insulin resistance (IR) in the early postnatal period are related to metabolism diseases in adulthood. However, previous studies on nutrition and growth or the body composition of preterm infants were mostly completed in developed countries, and no relevant data were available in China. Therefore, this study aims to establish a prospective cohort of very preterm infants to observe the effects of nutritional exposure in early life on growth and body composition in later life.
- Being tested
- Oral nutritional intake
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral nutritional intakeOther
Also called All nutritional intake, Insulin-like growth factor 1, Leptin, Ghrelin
The exposure are oral nutritional intake and all nutritional intake during early life (28 days), and insulin-like growth factor 1, leptin, Ghrelin, and C-peptide in serum at corrected age 40 gestational weeks.
| Study group | Role | What they receive |
|---|---|---|
| very preterm infants cohort | A prospective cohort of very preterm or very low birth weight infants from birth to corrected age 18 months. Receives: Other: Oral nutritional intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Z-scores of weight
Computed according to the Fenton preterm growth standards (2013)
Measured: at corrected age 40 gestational weeks
Secondary outcomes (11)
Z-scores of length/height
Computed according to the Fenton preterm growth standards (2013)
Measured: at corrected age 40 gestational weeks
Z-scores of head circumference
Computed according to the Fenton preterm growth standards (2013)
Measured: at corrected age 40 gestational weeks
Z-scores of weight
Computed according to the WHO standards (2006)
Measured: at corrected age 6 months and 18 months
Z-scores of length/height
Computed according to the WHO standards (2006)
Measured: at corrected age 6 months and 18 months
Z-scores of head circumference
Computed according to the WHO standards (2006)
Measured: at corrected age 6 months and 18 months
Percentage of infants who achieve catch-up growth
Catch-up growth is defined as weight, length/height or head circumference equal to or above the 25th percentile for corrected age, according to the WHO standards (2006).
Measured: at corrected age 6 months and 18 months
Body fat free mass
assessed by air displacement plethysmography (ADP)
Measured: at corrected age 40 gestational weeks and 6 months
Body fat mass
assessed by air displacement plethysmography (ADP)
Measured: at corrected age 40 gestational weeks and 6 months
Body fat proportion
assessed by air displacement plethysmography (ADP)
Measured: at corrected age 40 gestational weeks and 6 months
Cognitive development outcome
It is examined by six areas of development measured by Griffith Mental Development Scales (GMDS) including locomotor, personal-social, hearing and language, eye and hand co-ordination, performance and practical reasoning. Developmental impairment is defined as a developmental quotient lying one standard deviation below the mean (<85) and includes mild impairments (70-84) and moderate/severe impairment (<70).
Measured: at corrected age 18 months
Intestinal flora change
The change of composition of intestinal flora in preterm infants. The composition of intestinal flora was test by 16s rRNA sequencing.
Measured: from birth to corrected age 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start1 Aug 2019
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe 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 (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weili Yan, MD, PhD, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143204
- Sponsor's protocol ID
- NGPI2019
- Status last verified
- Feb 2023
- First submitted
- 26 Oct 2019
- Last updated
- 8 Feb 2023
- Results posted
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Nutritional Intake and Growth in Very Preterm or Very Low Birth Weight Infants: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04143204
- Acronym / sponsor ID
- NGPI2019
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 29 Oct 2019 (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.
This study aims to explore the relation of early nutritional intake, especially oral nutrition intake, with growth and body composition among very preterm or very low birth weight infants.
Detailed description
As the survival of very preterm infants increases, it is important to evaluate their long-term outcomes. Nutritional intake during early life was important to the growth and development in infants, especially in preterm infants. Studies found that early nutrition exposure in preterm infants can effect scored of Griffith Mental Development Scales and body fat percentage at later life. Insulin-like growth factor-1, leptin, Ghrelin, C-Peptide are associated with fat mass in children. And accumulation of fat and insulin resistance (IR) in the early postnatal period are related to metabolism diseases in adulthood. However, previous studies on nutrition and growth or the body composition of preterm infants were mostly completed in developed countries, and no relevant data were available in China. Therefore, this study aims to establish a prospective cohort of very preterm infants to observe the effects of nutritional exposure in early life on growth and body composition in later life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| very preterm infants cohort | – | Other: Oral nutritional intakeA prospective cohort of very preterm or very low birth weight infants from birth to corrected age 18 months. |
Who may qualify
- Ages
- 1 day to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Very preterm or very low birth weight infants in NICU
Key inclusion criteria (2 listed)
- infants born with a gestational age >=28 weeks and <32 weeks and/or a birth weight >=1000g and <1500g;
- infants admitted to neonatal intensive care unit (NICU) of Children's hospital of Fudan University within 24h after birth.
Key exclusion criteria (4 listed)
- major congenital anomalies or heredity metabolic diseases;
- severe disease or abdominal surgery during hospitalization;
- death during hospitalization or discharge without medical advice;
- small for gestational age.
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 |
|---|---|---|
| Oral nutritional intakeAlso: All nutritional intake, Insulin-like growth factor 1, Leptin, GhrelinThe exposure are oral nutritional intake and all nutritional intake during early life (28 days), and insulin-like growth factor 1, leptin, Ghrelin, and C-peptide in serum at corrected age 40 gestational weeks. | Other | very preterm infants cohort |
Primary outcome
Z-scores of weight
Time frame: at corrected age 40 gestational weeks
Computed according to the Fenton preterm growth standards (2013)
11 secondary outcomes
Z-scores of length/height
Time frame: at corrected age 40 gestational weeks
Z-scores of head circumference
Time frame: at corrected age 40 gestational weeks
Z-scores of weight
Time frame: at corrected age 6 months and 18 months
Z-scores of length/height
Time frame: at corrected age 6 months and 18 months
Z-scores of head circumference
Time frame: at corrected age 6 months and 18 months
Percentage of infants who achieve catch-up growth
Time frame: at corrected age 6 months and 18 months
Body fat free mass
Time frame: at corrected age 40 gestational weeks and 6 months
Body fat mass
Time frame: at corrected age 40 gestational weeks and 6 months
Body fat proportion
Time frame: at corrected age 40 gestational weeks and 6 months
Cognitive development outcome
Time frame: at corrected age 18 months
Intestinal flora change
Time frame: from birth to corrected age 18 months
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 Feb 2023.
- 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.
Weili Yan, MD, PhD principal investigator
Children's Hospital of Fudan University
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 and Growth, run by Children's Hospital of Fudan University 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 2 inclusion and 4 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 Feb 2023. 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?
Z-scores of weight (time frame: at corrected age 40 gestational weeks). 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 8 Feb 2023.