PrematurityNCT01860573
Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants
A study testing Amino acids in people with Prematurity, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial summary
The purpose of this study is to determine whether providing increased protein to premature infants in the first week of life allows for better growth during the hospital stay and improved developmental outcomes by age 2. Read more about this study
- Who is it for?
- Ages Up to 18 hours
- Conditions the study is for
- Prematurity
- What is being tested?
- Amino acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- birth weight 400 to 1250 grams
- 24 0/7 to 30 6/7 weeks gestational age
Who cannot join
- chromosomal, structural, metabolic, endocrine, or renal abnormalities that could affect growth
- infants >18 hours of age
- infants in extremis who are unlikely to survive past 72 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
About this study
The purpose of this study is to determine whether providing increased protein to premature infants in the first week of life allows for better growth during the hospital stay and improved developmental outcomes by age 2.
- Conditions
- Prematurity
- Being tested
- Amino acids
- Keywords
- Amino acids, Protein
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino acidsDrug
Also called Premasol
| Study group | Role | What they receive |
|---|---|---|
| Standard amino acids | Active comparator | Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day Receives: Drug: Amino acids |
| High amino acids | Experimental | Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth Receives: Drug: Amino acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Weight<10th Percentile for Age
Measured: 36 weeks post-conceptual age
Number of Participants With Length <10th Percentile for Age
Measured: 36 weeks post-conceptual age
Number of Participants With Head Circumference <10th Percentile for Age
Measured: 36 weeks post-conceptual age
Cognitive Development Score
Reported as units on a scale with mean of 100 and a Standard Deviation of 15, and range from 40-160. Higher values indicate a better outcome.
Measured: 18-22 months corrected gestational age
Secondary outcomes (3)
Serum Bicarbonate
Measured: Day of life 1, 2, 3, 5 and 7
Serum Creatinine
Measured: Day of life 1, 2, 3, 5 and 7
Serum Blood Urea Nitrogen
Measured: Day of life 1, 2, 3, 5 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startNov 2008
- Primary completionMar 2013
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Bliss, Women and Infants Hospital of Rhode Island
- Investigators
- Joseph M Bliss, MD, PhD, Principal investigator, Women and Infants Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860573
- Sponsor's protocol ID
- 08-0089
- Status last verified
- Feb 2017
- First submitted
- 14 May 2013
- Last updated
- 10 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Poindexter BB, Langer JC, Dusick AM, Ehrenkranz RA; National Institute of Child Health and Human Development Neonatal Research Network. Early provision of parenteral amino acids in extremely low birth weight infants: relation to growth and neurodevelopmental outcome. J Pediatr. 2006 Mar;148(3):300-305. doi: 10.1016/j.jpeds.2005.10.038.
PubMed 16615955Stephens BE, Walden RV, Gargus RA, Tucker R, McKinley L, Mance M, Nye J, Vohr BR. First-week protein and energy intakes are associated with 18-month developmental outcomes in extremely low birth weight infants. Pediatrics. 2009 May;123(5):1337-43. doi: 10.1542/peds.2008-0211.
PubMed 19403500Thureen PJ, Melara D, Fennessey PV, Hay WW Jr. Effect of low versus high intravenous amino acid intake on very low birth weight infants in the early neonatal period. Pediatr Res. 2003 Jan;53(1):24-32. doi: 10.1203/00006450-200301000-00008.
PubMed 12508078Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
PubMed 33006765
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants
- ClinicalTrials.gov ID
- NCT01860573
- Acronym / sponsor ID
- 08-0089
- Conditions
- Prematurity
- Keywords
- Amino acids, Protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 22 May 2013 (estimated)
- Results
- Posted 10 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether providing increased protein to premature infants in the first week of life allows for better growth during the hospital stay and improved developmental outcomes by age 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard amino acids | Active comparator | Drug: Amino acidsReceive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day |
| High amino acids | Experimental | Drug: Amino acidsReceive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth |
Who may qualify
- Ages
- Up to 18 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- birth weight 400 to 1250 grams
- 24 0/7 to 30 6/7 weeks gestational age
Key exclusion criteria (3 listed)
- chromosomal, structural, metabolic, endocrine, or renal abnormalities that could affect growth
- infants >18 hours of age
- infants in extremis who are unlikely to survive past 72 hours
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 |
|---|---|---|
| Amino acidsAlso: Premasol | Drug | High amino acids, Standard amino acids |
Primary outcome
Number of Participants With Weight<10th Percentile for Age
Time frame: 36 weeks post-conceptual age
Number of Participants With Length <10th Percentile for Age
Time frame: 36 weeks post-conceptual age
Number of Participants With Head Circumference <10th Percentile for Age
Time frame: 36 weeks post-conceptual age
Cognitive Development Score
Time frame: 18-22 months corrected gestational age
Reported as units on a scale with mean of 100 and a Standard Deviation of 15, and range from 40-160. Higher values indicate a better outcome.
3 secondary outcomes
Serum Bicarbonate
Time frame: Day of life 1, 2, 3, 5 and 7
Serum Creatinine
Time frame: Day of life 1, 2, 3, 5 and 7
Serum Blood Urea Nitrogen
Time frame: Day of life 1, 2, 3, 5 and 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16615955Poindexter BB, Langer JC, Dusick AM, Ehrenkranz RA; National Institute of Child Health and Human Development Neonatal Research Network. Early provision of parenteral amino acids in extremely low birth weight infants: relation to growth and neurodevelopmental outcome. J Pediatr. 2006 Mar;148(3):300-305. doi: 10.1016/j.jpeds.2005.10.038.
- Background: PubMed 19403500Stephens BE, Walden RV, Gargus RA, Tucker R, McKinley L, Mance M, Nye J, Vohr BR. First-week protein and energy intakes are associated with 18-month developmental outcomes in extremely low birth weight infants. Pediatrics. 2009 May;123(5):1337-43. doi: 10.1542/peds.2008-0211.
- Background: PubMed 12508078Thureen PJ, Melara D, Fennessey PV, Hay WW Jr. Effect of low versus high intravenous amino acid intake on very low birth weight infants in the early neonatal period. Pediatr Res. 2003 Jan;53(1):24-32. doi: 10.1203/00006450-200301000-00008.
- Derived from this study: PubMed 33006765Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
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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.
Joseph M Bliss, MD, PhD principal investigator
Women and Infants Hospital of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino acids in people with Prematurity, run by Women and Infants Hospital of Rhode Island at 1 site 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 10 Apr 2017. 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 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. 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?
Yes. Results are posted in the registry (first posted 10 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Weight<10th Percentile for Age (time frame: 36 weeks post-conceptual age). The study lists 4 primary outcomes in all. 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 NCT01860573, which also lists 4 linked publications.
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 10 Apr 2017.