Infant, Premature, DiseasesNCT02027688
Feeding Progression in Preterm Infants
A study testing q6 hour oral feeding schedule and q3 hour oral feeding schedule in people with Infant, Premature, Diseases and Feeding Behavior, run by University of Pennsylvania at 2 sites in United States.
Trial summary
Preterm infants face many feeding challenges during hospitalization which can prolong hospitalization, raise parental anxiety and can lead to medical instability. The Feeding Progression study will randomize preterm infants to one of two currently accepted oral feeding schedules; oral feed attempts every 3 hours or… Read more about this study
- Who is it for?
- Ages Up to 120 days
- Conditions the study is for
- Infant, Premature, Diseases, Feeding Behavior, Feeding Patterns
- What is being tested?
- q6 hour oral feeding schedule and q3 hour oral feeding schedule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to Apr 2015
- 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 120 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age between 23 0/7-33 0/7 weeks
- Eligible for oral (PO) feeding as determined by the attending Neonatologist
Who cannot join
- Infants with major congenital malformations
- Infants with chromosomal defects
- Diagnosis of Neonatal Abstinence Syndrome or opiate withdrawal
- Grade 3 or 4 Intraventricular Hemorrhage
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
About this study
Preterm infants face many feeding challenges during hospitalization which can prolong hospitalization, raise parental anxiety and can lead to medical instability. The Feeding Progression study will randomize preterm infants to one of two currently accepted oral feeding schedules; oral feed attempts every 3 hours or every 6 hours. The study will collect data on oral feeding success, milk transfer, sucking strength, growth and medical complications.
Read the detailed description
Preterm infants are at high risk for feeding issues. Feeding difficulties lead to prolonged hospitalization, increase medical complications and raise parental anxiety. The transition from tube feeding to oral feeding is an especially important step in a preterm infant's early life. Currently, there is limited evidence to guide this transition. There are two commonly used schedules for transitioning preterm infants to oral feeding: an every 6 hour schedule and an every 3 hour schedule. However, there is currently no evidence to guide providers in their choice of oral feeding schedule.
The primary objective of this study is to explore whether an every 6 (q6) hour oral feeding schedule will improve time to full oral feedings as compared to an every 3 (q3) hour oral feeding schedule. The secondary objectives are to test whether every 6 hour feeding allows for improved medical stability and oral-motor coordination as compared to the other commonly used q3 hour schedule. Each infant will be randomly assigned to a q6 hour or q3 hour oral feeding schedule. Data on oral feeding progression, respiratory status and oral motor proficiency will be collected and compared. The study will collect data on how long it takes each infant to get to full oral feeds, respiratory status throughout their time of oral feeding, whether there were any episodes of medical complications, measures of oral motor feeding skills, and the time to discharge from the hospital. This study is a crucial first step towards determining which feeding schedule is optimal for preterm infants to ensure timely attainment of full oral feeds and hospital discharge without compromising medical stability.
- Being tested
- q6 hour oral feeding schedule, q3 hour oral feeding schedule
- Keywords
- Oral feeding, Premature, Infants, Neonatal Intensive Care Unit
- Medical subject headings
- Infant, Premature, Diseases, Feeding Behavior, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
q6 hour oral feeding scheduleOther
The intervention is the schedule under which stable infants are offered oral feeding attempts: every 6 hours.
q3 hour oral feeding scheduleOther
The intervention is the schedule under which stable infants are offered oral feeding attempts: every 3 hours.
| Study group | Role | What they receive |
|---|---|---|
| Every 6 hour Feeding Schedule | Active comparator | Infants in this arm will be offered oral feedings every 6 hours if they are safe and ready to feed by mouth. Receives: Other: q6 hour oral feeding schedule |
| Every 3 Hour Oral Feeding | Active comparator | Infants in this arm will be offered oral feedings every 3 hours if they are safe and ready to feed by mouth. Receives: Other: q3 hour oral feeding schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to full oral feeds
Assess the relationship between feeding schedule and time to reach full oral feeds in preterm infants.
Measured: 38 weeks gestation on average
Secondary outcomes (4)
Time to discharge
Assess the relationship between feeding schedule and overall length of hospitalization.
Measured: 40 weeks gestation on average
Medical Complications
Explore the relationship between feeding schedule and medical complications including apnea of prematurity, bronchopulmonary dysplasia, episodes of suspected sepsis, feeding intolerance and physiologic instability during the time of oral feeds.
Measured: 38 weeks gestation on average
Growth
Assess the growth during the period of time from initiation of oral feeds to reaching complete oral feeds.
Measured: 40 weeks gestation on average
Feeding skills
Assess feeding competence and sucking skills from initiation of feeds through discharge on full oral feeds.
Measured: 40 weeks gestation on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startJul 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Principal investigator, Sara DeMauro, University of Pennsylvania
- Investigators
- Sara B DeMauro, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027688
- Sponsor's protocol ID
- 819247
- Status last verified
- Dec 2015
- First submitted
- 31 Dec 2013
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding Progression in Preterm Infants
- ClinicalTrials.gov ID
- NCT02027688
- Acronym / sponsor ID
- 819247
- Keywords
- Oral feeding, Premature, Infants, Neonatal Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- Jul 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 6 Jan 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.
Preterm infants face many feeding challenges during hospitalization which can prolong hospitalization, raise parental anxiety and can lead to medical instability. The Feeding Progression study will randomize preterm infants to one of two currently accepted oral feeding schedules; oral feed attempts every 3 hours or every 6 hours. The study will collect data on oral feeding success, milk transfer, sucking strength, growth and medical complications.
Detailed description
Preterm infants are at high risk for feeding issues. Feeding difficulties lead to prolonged hospitalization, increase medical complications and raise parental anxiety. The transition from tube feeding to oral feeding is an especially important step in a preterm infant's early life. Currently, there is limited evidence to guide this transition. There are two commonly used schedules for transitioning preterm infants to oral feeding: an every 6 hour schedule and an every 3 hour schedule. However, there is currently no evidence to guide providers in their choice of oral feeding schedule.
The primary objective of this study is to explore whether an every 6 (q6) hour oral feeding schedule will improve time to full oral feedings as compared to an every 3 (q3) hour oral feeding schedule. The secondary objectives are to test whether every 6 hour feeding allows for improved medical stability and oral-motor coordination as compared to the other commonly used q3 hour schedule. Each infant will be randomly assigned to a q6 hour or q3 hour oral feeding schedule. Data on oral feeding progression, respiratory status and oral motor proficiency will be collected and compared. The study will collect data on how long it takes each infant to get to full oral feeds, respiratory status throughout their time of oral feeding, whether there were any episodes of medical complications, measures of oral motor feeding skills, and the time to discharge from the hospital. This study is a crucial first step towards determining which feeding schedule is optimal for preterm infants to ensure timely attainment of full oral feeds and hospital discharge without compromising medical stability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Every 6 hour Feeding Schedule | Active comparator | Other: q6 hour oral feeding scheduleInfants in this arm will be offered oral feedings every 6 hours if they are safe and ready to feed by mouth. |
| Every 3 Hour Oral Feeding | Active comparator | Other: q3 hour oral feeding scheduleInfants in this arm will be offered oral feedings every 3 hours if they are safe and ready to feed by mouth. |
Who may qualify
- Ages
- Up to 120 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Gestational age between 23 0/7-33 0/7 weeks
- Eligible for oral (PO) feeding as determined by the attending Neonatologist
Key exclusion criteria (4 listed)
- Infants with major congenital malformations
- Infants with chromosomal defects
- Diagnosis of Neonatal Abstinence Syndrome or opiate withdrawal
- Grade 3 or 4 Intraventricular Hemorrhage
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 |
|---|---|---|
| q6 hour oral feeding scheduleThe intervention is the schedule under which stable infants are offered oral feeding attempts: every 6 hours. | Other | Every 6 hour Feeding Schedule |
| q3 hour oral feeding scheduleThe intervention is the schedule under which stable infants are offered oral feeding attempts: every 3 hours. | Other | Every 3 Hour Oral Feeding |
Primary outcome
Time to full oral feeds
Time frame: 38 weeks gestation on average
Assess the relationship between feeding schedule and time to reach full oral feeds in preterm infants.
4 secondary outcomes
Time to discharge
Time frame: 40 weeks gestation on average
Medical Complications
Time frame: 38 weeks gestation on average
Growth
Time frame: 40 weeks gestation on average
Feeding skills
Time frame: 40 weeks gestation on average
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 2 Dec 2015.
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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.
Sara B DeMauro, MD, MSCE principal investigator
Children's Hospital of Philadelphia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing q6 hour oral feeding schedule and q3 hour oral feeding schedule in people with Infant, Premature, Diseases and Feeding Behavior, run by University of Pennsylvania 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 4 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 2 Dec 2015. 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. 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?
Time to full oral feeds (time frame: 38 weeks gestation on average). 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 2 Dec 2015.