Other Preterm InfantsNCT02073071
Effects of Infant Formula on the Growth and Tolerance in Preterm/Low Birth Weight Infants
An observational study of Other Preterm Infants, run by Abbott Nutrition at 10 sites in China.
Trial summary
This is a two stage open-label, single-arm, multicenter and observational study. Read more about this study
- Who is it for?
- Ages Up to 21 days
- Conditions the study is for
- Other Preterm Infants
- How many people
- 139 participants
- Where
- 10 sitesChina
- Study dates
- May 2014to Nov 2015
- 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 Up to 21 days
- All sexes
- No healthy volunteers
- Child
Study population: Hospital based preterm infants
Who may be able to join
- Less than or equal to 34 weeks gestational age at birth, and birth weight ≥ 1000g to < 1800g;
- Apgar score in 5 minutes after birth ≥ 7;
- Infant is 21 days or less of age at enrollment;
- Only singleton or twin births;
- Infants who can receive early enteral feeding stably (reaching 50% or higher of the required daily total calories) and whose parents/guardians and investigators have selected Similac Special Care (SSC) for feeding;
- Infant has been classified as appropriate for gestational age (AGA) or if classified as asymmetric small for gestational age (SGA) (Asymmetric SGA: Weight below the 10th percentile, but head circumference is greater than or equal to the 10th percentile) enrollment has been preapproved by sponsor;
- Infants with birth weight < or = 1500g, subjects whose parents/guardians and investigators have selected NeoSure for continued feeding after hospital discharge.
Who cannot join
- Serious congenital chromosomal or metabolic abnormalities that may affect growth and development;
- Congenital gastrointestinal malformations , including but not limited to congenital megacolon or gastric-intestinal perforation;
- Serious complications associated with preterm birth, including but not limited to necrotizing enterocolitis (NEC), septicemia or sepsis;
- Other serious disorders of cardiac/respiratory/endocrine/hematological/ gastrointestinal/other systems, or serious diseases requiring surgical intervention;
- Maternal incapacity: including maternal drug, cocaine or alcohol abuse during pregnancy or current;
- Infants who received any experimental treatment, participated in other clinical trials or received other study interventions unrelated to this study within 30 days prior to enrollment;
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- Infants who have received or planned to receive breastfeeding or other infant formula (powder) other than SSC with calories intake ≥25% of the required daily total calories
- Intubation for ventilation at the time of enrollment.
- Infants who have received breastfeeding or other infant formula (powder) during hospitalization other than SSC with calories intake ≥25% of the required daily total calories
- Infants who have planned to receive breastfeeding or other infant formula (powder) other than NeoSure after discharge with calories intake ≥25% of the required daily total calories
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Peking University First Hospital
Beijing
Hunan Children's Hospital
Changsha, Hunan
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Children's hospital of Chongqing Medical University
Chongqing
Guangdong General Hospital
Guangzhou, Guangdong
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, Zhejiang
Children's Hospital of Shanghai
Shanghai
Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
About this study
This is a two stage open-label, single-arm, multicenter and observational study.
Read the detailed description
Stage 1: In hospital, preterm/low birth weight infants less than or equal to 34 weeks gestational age at birth, birth weight of ≥ 1000g to <1800g and conditions meeting the enrollment criteria will be fed formula with or without parenteral nutrition until discharge. Stage 2: Post-discharge, all infants with birth weight < or =1500g will be followed on formula per standard of care and accepted standard of care including feeding until the infant's weight >or= 25th percentile of growth expectation based on corrected age (P25) or until infant reaches 9 months corrected age.
- Conditions
- Other Preterm Infants
- Being tested
- Preterm infant formula per standard of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preterm infant formula per standard of careOther
Commercially available preterm infant formula
| Study group | Role | What they receive |
|---|---|---|
| Preterm/low birth weight infants | Preterm infant formula per standard of care Receives: Other: Preterm infant formula per standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: Change from first feeding to discharge (up to ~8 weeks)
Secondary outcomes (5)
Length
Measured: Change from first feeding to discharge (up to ~8 weeks)
Head Circumference
Measured: Change from first feeding to discharge (up to ~8 weeks)
Hospitalization Length of Stay
Measured: Time from Birth to discharge (up to ~8 weeks)
Gastrointestinal Tolerance
vomiting, abdominal distension, gastric residuals, stool abnormalities, necrotizing enterocolitis
Measured: From first feeding to discharge (up to ~8 weeks)
Catch Up Growth
From discharge to the time point that infant's weight >or= 25th percentile of growth expectation based on corrected age (P25) or until infant reaches 9 months corrected age.
Measured: From discharge to 9 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Preterm InfantsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xianfeng Zhao, MD, PhD, Study chair, Abbott Nutrition China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073071
- Sponsor's protocol ID
- DA05
- Status last verified
- Nov 2015
- First submitted
- 19 Feb 2014
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Infant Formula on the Growth and Tolerance in Preterm/Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT02073071
- Acronym / sponsor ID
- DA05
- Conditions
- Other Preterm Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 27 Feb 2014 (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 is a two stage open-label, single-arm, multicenter and observational study.
Detailed description
Stage 1: In hospital, preterm/low birth weight infants less than or equal to 34 weeks gestational age at birth, birth weight of ≥ 1000g to <1800g and conditions meeting the enrollment criteria will be fed formula with or without parenteral nutrition until discharge. Stage 2: Post-discharge, all infants with birth weight < or =1500g will be followed on formula per standard of care and accepted standard of care including feeding until the infant's weight >or= 25th percentile of growth expectation based on corrected age (P25) or until infant reaches 9 months corrected age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm/low birth weight infants | – | Other: Preterm infant formula per standard of carePreterm infant formula per standard of care |
Who may qualify
- Ages
- Up to 21 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Hospital based preterm infants
Key inclusion criteria (7 listed)
- Less than or equal to 34 weeks gestational age at birth, and birth weight ≥ 1000g to < 1800g;
- Apgar score in 5 minutes after birth ≥ 7;
- Infant is 21 days or less of age at enrollment;
- Only singleton or twin births;
- Infants who can receive early enteral feeding stably (reaching 50% or higher of the required daily total calories) and whose parents/guardians and investigators have selected Similac Special Care (SSC) for feeding;
Key exclusion criteria (10 listed)
- Serious congenital chromosomal or metabolic abnormalities that may affect growth and development;
- Congenital gastrointestinal malformations , including but not limited to congenital megacolon or gastric-intestinal perforation;
- Serious complications associated with preterm birth, including but not limited to necrotizing enterocolitis (NEC), septicemia or sepsis;
- Other serious disorders of cardiac/respiratory/endocrine/hematological/ gastrointestinal/other systems, or serious diseases requiring surgical intervention;
- Maternal incapacity: including maternal drug, cocaine or alcohol abuse during pregnancy or current;
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 |
|---|---|---|
| Preterm infant formula per standard of careCommercially available preterm infant formula | Other | Preterm/low birth weight infants |
Primary outcome
Weight
Time frame: Change from first feeding to discharge (up to ~8 weeks)
5 secondary outcomes
Length
Time frame: Change from first feeding to discharge (up to ~8 weeks)
Head Circumference
Time frame: Change from first feeding to discharge (up to ~8 weeks)
Hospitalization Length of Stay
Time frame: Time from Birth to discharge (up to ~8 weeks)
Gastrointestinal Tolerance
Time frame: From first feeding to discharge (up to ~8 weeks)
Catch Up Growth
Time frame: From discharge to 9 months corrected age
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 30 Nov 2015.
Related trials for Other Preterm Infants
Recruiting
Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)
Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
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.
Xianfeng Zhao, MD, PhD study chair
Abbott Nutrition China
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Other Preterm Infants, run by Abbott Nutrition at 10 sites 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 7 inclusion and 10 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 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Weight (time frame: Change from first feeding to discharge (up to ~8 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 30 Nov 2015.