PrematurityPhase 2/3NCT01787019
Initiation of Oral Feeding at 30 Versus 33 Weeks Postmenstrual Age
A Phase 2/3 study testing Oral feeding in people with Prematurity, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of the study is to determine if earlier initiation of oral (by mouth as opposed to tube) feedings in premature infants results in earlier attainment of full oral feedings and/or discharge. Read more about this study
- Who is it for?
- Ages Up to 7 weeks
- Conditions the study is for
- Prematurity
- What is being tested?
- Oral feeding
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Apr 2016
- Phase
- Phase 2/3
- 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 7 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age <= 29 weeks at birth
- Tolerating enteral feedings for at least 3 days before 30 weeks postmenstrual age
Who cannot join
- Neurologic, cardiac, respiratory, or gastrointestinal disorders that interfere with oral feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Memorial Hermann Hospital
Houston, Texas, 77030
About this study
The purpose of the study is to determine if earlier initiation of oral (by mouth as opposed to tube) feedings in premature infants results in earlier attainment of full oral feedings and/or discharge.
Read the detailed description
Infants will be enrolled and randomized at 30 0/7 weeks postmenstrual age. The Earlier Oral Feeding group will initiate oral feedings at 30 0/7 weeks postmenstrual age. The Later Oral Feeding group will initiate oral feedings at 33 0/7 weeks postmenstrual age. The number of oral feeding attempts will be advanced according to a feeding progression protocol for both groups. Successful completion of a feeding is defined as oral completion of the full volume of a feeding within 30 minutes, without a bradycardic episode (heart rate <100 beats per minute) or desaturation (oxygen saturation decrease >5% from baseline values). If infant does not successfully complete >95% of the total prescribed volume of a feeding, the remainder of the volume will be supplied via gastric tube. All oral feedings will be performed by bedside nurses, or by a parent with observation by the nursing staff, with continuous cardiorespiratory and pulse oximetry monitoring. Individual oral feeding attempts for both groups will continue until one of the following occurs despite appropriate pacing of the feeding: 1) the feeding is completed 2) feeding duration of 30 minutes 3) adverse event during a feeding [multiple bradycardic episodes (3 episodes of heart rate <100 beats per minute), bradycardia with choking episode, single severe bradycardia (heart rate <60)]. If the infant experiences an adverse event during an oral feeding attempt, oral feeding attempts will be held for 2 days.
- Conditions
- Prematurity
- Being tested
- Oral feeding
- 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 feedingOther
| Study group | Role | What they receive |
|---|---|---|
| 30 weeks | Experimental | initiation of oral feedings at 30 weeks Receives: Other: Oral feeding |
| 33 weeks | Active comparator | initiation of oral feedings at 33 weeks Receives: Other: Oral feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postmenstrual age at full oral feeding
defined as the infant orally consuming the volume of formula/breastmilk as prescribed by the attending physician without requiring gavage feedings for 2 days
Measured: until hospital discharge (typically 36 weeks postmenstrual age)
Secondary outcomes (2)
postmenstrual age at discharge
Measured: until hospital discharge (typically 36 weeks postmenstrual age)
growth between enrollment and 36 weeks postmenstrual age
Measured: until hospital discharge (typically 36 weeks postmenstrual age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Kennedy, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787019
- Sponsor's protocol ID
- Age of Oral Feeding
- Status last verified
- May 2016
- First submitted
- 4 Feb 2013
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiation of Oral Feeding at 30 Versus 33 Weeks Postmenstrual Age
- ClinicalTrials.gov ID
- NCT01787019
- Acronym / sponsor ID
- Age of Oral Feeding
- Conditions
- Prematurity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 8 Feb 2013 (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 purpose of the study is to determine if earlier initiation of oral (by mouth as opposed to tube) feedings in premature infants results in earlier attainment of full oral feedings and/or discharge.
Detailed description
Infants will be enrolled and randomized at 30 0/7 weeks postmenstrual age. The Earlier Oral Feeding group will initiate oral feedings at 30 0/7 weeks postmenstrual age. The Later Oral Feeding group will initiate oral feedings at 33 0/7 weeks postmenstrual age. The number of oral feeding attempts will be advanced according to a feeding progression protocol for both groups. Successful completion of a feeding is defined as oral completion of the full volume of a feeding within 30 minutes, without a bradycardic episode (heart rate <100 beats per minute) or desaturation (oxygen saturation decrease >5% from baseline values). If infant does not successfully complete >95% of the total prescribed volume of a feeding, the remainder of the volume will be supplied via gastric tube. All oral feedings will be performed by bedside nurses, or by a parent with observation by the nursing staff, with continuous cardiorespiratory and pulse oximetry monitoring. Individual oral feeding attempts for both groups will continue until one of the following occurs despite appropriate pacing of the feeding: 1) the feeding is completed 2) feeding duration of 30 minutes 3) adverse event during a feeding [multiple bradycardic episodes (3 episodes of heart rate <100 beats per minute), bradycardia with choking episode, single severe bradycardia (heart rate <60)]. If the infant experiences an adverse event during an oral feeding attempt, oral feeding attempts will be held for 2 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 weeks | Experimental | Other: Oral feedinginitiation of oral feedings at 30 weeks |
| 33 weeks | Active comparator | Other: Oral feedinginitiation of oral feedings at 33 weeks |
Who may qualify
- Ages
- Up to 7 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Gestational age <= 29 weeks at birth
- Tolerating enteral feedings for at least 3 days before 30 weeks postmenstrual age
Key exclusion criteria (1 listed)
- Neurologic, cardiac, respiratory, or gastrointestinal disorders that interfere with oral feeding
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 feeding | Other | 30 weeks, 33 weeks |
Primary outcome
Postmenstrual age at full oral feeding
Time frame: until hospital discharge (typically 36 weeks postmenstrual age)
defined as the infant orally consuming the volume of formula/breastmilk as prescribed by the attending physician without requiring gavage feedings for 2 days
2 secondary outcomes
postmenstrual age at discharge
Time frame: until hospital discharge (typically 36 weeks postmenstrual age)
growth between enrollment and 36 weeks postmenstrual age
Time frame: until hospital discharge (typically 36 weeks postmenstrual 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 13 May 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oral feeding in people with Prematurity, run by The University of Texas Health Science Center, Houston 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 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 13 May 2016. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Postmenstrual age at full oral feeding (time frame: until hospital discharge (typically 36 weeks postmenstrual age)). 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 13 May 2016.