PrematurityNCT03192839
Early DHA Supplementation in Very Low Birth Weight Infants
A study testing Low dose PUFA and High dose PUFA in people with Prematurity, run by Mead Johnson Nutrition at 2 sites in United States.
Trial summary
This clinical trial will evaluate the effects of giving supplements of PUFA to premature infants. Read more about this study
- Who is it for?
- Ages Up to 3 days
- Conditions the study is for
- Prematurity
- What is being tested?
- Low dose PUFA and High dose PUFA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2017to 30 Aug 2018
- Phase
- Interventional
- 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 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Very low birth weight infants weighing less than 1500 grams
- Consent signed within 72 hours of life
Who cannot join
- Infants with know metabolic disorder
- Infants with known congenital GI anomaly
- Infants who are deemed to be inappropriate for enrollment per attending neonatologist
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rush University Medical Center
Chicago, Illinois, 60612
North Shore University Health System
Evanston, Illinois, 60201
About this study
This clinical trial will evaluate the effects of giving supplements of PUFA to premature infants.
- Conditions
- Prematurity
- Being tested
- Low dose PUFA, High dose PUFA, Placebo
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose PUFAOther
Low dose PUFA
High dose PUFAOther
High dose PUFA
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Low dose PUFA | Experimental | Not described Receives: Other: Low dose PUFA |
| High dose PUFA | Experimental | Not described Receives: Other: High dose PUFA |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red Blood Cell polyunsaturated fatty acids (PUFA) levels
Measured: 2 weeks of age
Secondary outcomes (4)
Red Blood Cell PUFA levels
Measured: 8 weeks of age
Feeding tolerance
Full enteral feed of 120 kcal/kg/day
Measured: 8 weeks
Incidence of necrotizing enterocolitis
Measured: 8 weeks
Incidence of bronchopulmonary dysplasia
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start1 Jul 2017
- Primary completion9 Jul 2018
- Study completion30 Aug 2018
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 PrematurityStudies 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- North Shore Research Institue
- Responsible party
- Sponsor
- Investigators
- Timothy Cooper, M.D, Study director, Mead Johnson Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192839
- Sponsor's protocol ID
- 6039
- Status last verified
- May 2019
- First submitted
- 19 Jun 2017
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frost BL, Patel AL, Robinson DT, Berseth CL, Cooper T, Caplan M. Randomized Controlled Trial of Early Docosahexaenoic Acid and Arachidonic Acid Enteral Supplementation in Very Low Birth Weight Infants. J Pediatr. 2021 May;232:23-30.e1. doi: 10.1016/j.jpeds.2020.12.037. Epub 2021 Feb 20.
PubMed 33358843
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early DHA Supplementation in Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT03192839
- Acronym / sponsor ID
- 6039
- Conditions
- Prematurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Collaborators
- North Shore Research Institue
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 9 Jul 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 20 Jun 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.
This clinical trial will evaluate the effects of giving supplements of PUFA to premature infants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose PUFA | Experimental | Other: Low dose PUFA |
| High dose PUFA | Experimental | Other: High dose PUFA |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Very low birth weight infants weighing less than 1500 grams
- Consent signed within 72 hours of life
Key exclusion criteria (3 listed)
- Infants with know metabolic disorder
- Infants with known congenital GI anomaly
- Infants who are deemed to be inappropriate for enrollment per attending neonatologist
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 |
|---|---|---|
| Low dose PUFALow dose PUFA | Other | Low dose PUFA |
| High dose PUFAHigh dose PUFA | Other | High dose PUFA |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Red Blood Cell polyunsaturated fatty acids (PUFA) levels
Time frame: 2 weeks of age
4 secondary outcomes
Red Blood Cell PUFA levels
Time frame: 8 weeks of age
Feeding tolerance
Time frame: 8 weeks
Incidence of necrotizing enterocolitis
Time frame: 8 weeks
Incidence of bronchopulmonary dysplasia
Time frame: 8 weeks
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 7 May 2019.
- Derived from this study: PubMed 33358843Frost BL, Patel AL, Robinson DT, Berseth CL, Cooper T, Caplan M. Randomized Controlled Trial of Early Docosahexaenoic Acid and Arachidonic Acid Enteral Supplementation in Very Low Birth Weight Infants. J Pediatr. 2021 May;232:23-30.e1. doi: 10.1016/j.jpeds.2020.12.037. Epub 2021 Feb 20.
- Individual participant dataSharing planned: No
Related trials for Prematurity
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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.
Timothy Cooper, M.D study director
Mead Johnson Nutrition
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose PUFA and High dose PUFA in people with Prematurity, run by Mead Johnson Nutrition at 2 sites in United States.
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 3 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 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Red Blood Cell polyunsaturated fatty acids (PUFA) levels (time frame: 2 weeks of age). 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 NCT03192839, 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 7 May 2019.