Infant PrematureNCT02377050
Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates
A study testing Higher Volume Feeding Goal in people with Infant Premature, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The primary hypothesis is that preterm infants who are less than or equal to 32 weeks gestation and weigh 1001-2500 grams at birth will have an increase in weight gain with a feeding goal of 180-200 ml/kg/day more than the commonly used feeding goal of 140-160 ml/kg/day Read more about this study
- Who is it for?
- Ages 1 day to 1 month
- Conditions the study is for
- Infant Premature
- What is being tested?
- Higher Volume Feeding Goal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jun 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 1 day to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inborn or outborn infants born at a gestational age of 32 weeks or less; Birthweight 1001-2500; Feeding volume of at least 120 ml/kg/day; Enrolled prior to 28 days of age and prior to exceeding 32 weeks
Who cannot join
- Hemodynamically significant patent ductus arteriosis; History of necrotizing enterocolitis Bell Stage II or greater; Known gastrointestinal or neurologic malformations; Prior or planned enrollment into the NICHD MILK Trial; Terminal illness or decision to withhold or limit support
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this study
The primary hypothesis is that preterm infants who are less than or equal to 32 weeks gestation and weigh 1001-2500 grams at birth will have an increase in weight gain with a feeding goal of 180-200 ml/kg/day more than the commonly used feeding goal of 140-160 ml/kg/day
Read the detailed description
The proposed trial is designed to test the primary hypothesis that in preterm infants weighing 1001-2500 grams at birth and who are less than or equal to 32 weeks gestation, feeding goals of 180-200 ml/kg/day will increase weight gain (g/k/day) from time of enrollment to discharge home or 36 weeks post-menstrual age (PMA)(whichever comes first) more than the commonly used feeding goal volume of 140-160 ml/kg/day (usual feeding goal). This is a pilot study to determine the safety of increased volumes of feedings as opposed to fortification of feedings.
- Conditions
- Infant Premature
- Being tested
- Higher Volume Feeding Goal
- Keywords
- Nutritional support
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Higher Volume Feeding GoalOther
feeding volume goal of 180-200 ml/kg/day
| Study group | Role | What they receive |
|---|---|---|
| Higher Volume Feeding Goal | Active comparator | Infants randomized to this group will have higher volume feeding goals of 180-200 ml/kg/day. Receives: Other: Higher Volume Feeding Goal |
| Usual Volume Feeding Goal | No intervention | Infants randomized to this group will have feeding goals of 140-160 ml/kg/day. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
Average change in weight between baseline and 12 weeks
Measured: baseline to average 12 weeks of age
Secondary outcomes (9)
Mid arm circumference
average change in mid arm circumference between baseline and 12 weeks
Measured: baseline to average 12 weeks of age
Length
average change in length between baseline and 12 weeks
Measured: baseline to average 12 weeks of age
Head circumference
average change in head circumference between baseline and 12 weeks
Measured: baseline to average 12 weeks of age
Caloric intake
Average difference in weekly caloric intake between groups
Measured: 36 weeks
Length of stay
Days from study entry to discharge home
Measured: 36 weeks or discharge
Rates of infants less than 10th percentile for weight
Rates of infants less than 10th percentile for weight at study completion
Measured: 36 weeks or discharge
Change in weight z score
Change in weight z score from study entry to completion
Measured: 36 weeks or discharge
Change in length z score
Change in length z score from study entry to completion
Measured: 36 weeks or discharge
Change in head circumference z score
Change in head circumference z score from study entry to completion
Measured: 36 weeks or discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant PrematureStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colm Travers, University of Alabama at Birmingham
- Investigators
- Waldemar A Carlo, MD, Study director, University of Alabama at BirminghamColm Travers, MD, Principal investigator, University of Alabama at BirminghamAriel A Salas, MD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377050
- Sponsor's protocol ID
- UAB NEO 013
- Status last verified
- Jun 2018
- First submitted
- 1 Dec 2014
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Salas AA, Travers CP, Jerome ML, Chandler-Laney P, Carlo WA. Percent Body Fat Content Measured by Plethysmography in Infants Randomized to High- or Usual-Volume Feeding after Very Preterm Birth. J Pediatr. 2021 Mar;230:251-254.e3. doi: 10.1016/j.jpeds.2020.11.028. Epub 2020 Nov 25.
PubMed 33248115Travers CP, Wang T, Salas AA, Schofield E, Dills M, Laney D, Yee A, Bhatia A, Winter L, Ambalavanan N, Carlo WA. Higher- or Usual-Volume Feedings in Infants Born Very Preterm: A Randomized Clinical Trial. J Pediatr. 2020 Sep;224:66-71.e1. doi: 10.1016/j.jpeds.2020.05.033. Epub 2020 May 25.
PubMed 32464224
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates
- ClinicalTrials.gov ID
- NCT02377050
- Acronym / sponsor ID
- UAB NEO 013
- Conditions
- Infant Premature
- Keywords
- Nutritional support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 3 Mar 2015 (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.
The primary hypothesis is that preterm infants who are less than or equal to 32 weeks gestation and weigh 1001-2500 grams at birth will have an increase in weight gain with a feeding goal of 180-200 ml/kg/day more than the commonly used feeding goal of 140-160 ml/kg/day
Detailed description
The proposed trial is designed to test the primary hypothesis that in preterm infants weighing 1001-2500 grams at birth and who are less than or equal to 32 weeks gestation, feeding goals of 180-200 ml/kg/day will increase weight gain (g/k/day) from time of enrollment to discharge home or 36 weeks post-menstrual age (PMA)(whichever comes first) more than the commonly used feeding goal volume of 140-160 ml/kg/day (usual feeding goal). This is a pilot study to determine the safety of increased volumes of feedings as opposed to fortification of feedings.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Higher Volume Feeding Goal | Active comparator | Other: Higher Volume Feeding GoalInfants randomized to this group will have higher volume feeding goals of 180-200 ml/kg/day. |
| Usual Volume Feeding Goal | No intervention | –Infants randomized to this group will have feeding goals of 140-160 ml/kg/day. |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Inborn or outborn infants born at a gestational age of 32 weeks or less; Birthweight 1001-2500; Feeding volume of at least 120 ml/kg/day; Enrolled prior to 28 days of age and prior to exceeding 32 weeks
Key exclusion criteria (1 listed)
- Hemodynamically significant patent ductus arteriosis; History of necrotizing enterocolitis Bell Stage II or greater; Known gastrointestinal or neurologic malformations; Prior or planned enrollment into the NICHD MILK Trial; Terminal illness or decision to withhold or limit support
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 |
|---|---|---|
| Higher Volume Feeding Goalfeeding volume goal of 180-200 ml/kg/day | Other | Higher Volume Feeding Goal |
Primary outcome
Weight gain
Time frame: baseline to average 12 weeks of age
Average change in weight between baseline and 12 weeks
9 secondary outcomes
Mid arm circumference
Time frame: baseline to average 12 weeks of age
Length
Time frame: baseline to average 12 weeks of age
Head circumference
Time frame: baseline to average 12 weeks of age
Caloric intake
Time frame: 36 weeks
Length of stay
Time frame: 36 weeks or discharge
Rates of infants less than 10th percentile for weight
Time frame: 36 weeks or discharge
Change in weight z score
Time frame: 36 weeks or discharge
Change in length z score
Time frame: 36 weeks or discharge
Change in head circumference z score
Time frame: 36 weeks or discharge
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 18 Jun 2018.
- Derived from this study: PubMed 33248115Salas AA, Travers CP, Jerome ML, Chandler-Laney P, Carlo WA. Percent Body Fat Content Measured by Plethysmography in Infants Randomized to High- or Usual-Volume Feeding after Very Preterm Birth. J Pediatr. 2021 Mar;230:251-254.e3. doi: 10.1016/j.jpeds.2020.11.028. Epub 2020 Nov 25.
- Derived from this study: PubMed 32464224Travers CP, Wang T, Salas AA, Schofield E, Dills M, Laney D, Yee A, Bhatia A, Winter L, Ambalavanan N, Carlo WA. Higher- or Usual-Volume Feedings in Infants Born Very Preterm: A Randomized Clinical Trial. J Pediatr. 2020 Sep;224:66-71.e1. doi: 10.1016/j.jpeds.2020.05.033. Epub 2020 May 25.
Related trials for Infant Premature
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)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
Waldemar A Carlo, MD study director
University of Alabama at Birmingham
Colm Travers, MD principal investigator
University of Alabama at Birmingham
Ariel A Salas, MD
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Higher Volume Feeding Goal in people with Infant Premature, run by University of Alabama at Birmingham 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 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 18 Jun 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 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?
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 gain (time frame: baseline to average 12 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 NCT02377050, which also lists 2 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 18 Jun 2018.