Bronchopulmonary DysplasiaNCT02142621
Transpyloric Feeding in Severe Bronchopulmonary Dysplasia
A study testing transpyloric feeding and gastric feeding in people with Bronchopulmonary Dysplasia, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Bronchopulmonary dysplasia (BPD) is the most common complication of extreme preterm birth. It impacts 10,000-15,000 infants in the US annually, including approximately 50% of infants with birth weight < 1000g. Read more about this study
- Who is it for?
- Ages 4 to 24 weeks
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- transpyloric feeding and gastric feeding
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2014to 15 Jul 2016
- 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 4 to 24 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age ≤ 32 weeks
- Severe BPD (FiO2 ≥ 30% and/or mechanical ventilation or non-invasive positive pressure respiratory support at the time of enrollment)
- Post menstrual age of 36-45 6/7 weeks at enrollment
- Parent and/or guardian permission (informed consent)
Who cannot join
- Prior intolerance to transpyloric feeds
- History of surgical anti-reflux procedure
- Congenital heart disease (not including patent ductus arterioles and hemodynamically insignificant ventricular septal defect or atrial septal defect)
- Structural abnormalities of the upper airway, lungs, or chest wall
- Other congenital malformations or syndromes that adversely affect life expectancy or cardio-pulmonary development
- Parent, guardian, or subject who, in the opinion of the investigators, are unlikely to participate for the duration of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Pilot N-of-1 Multiple Crossover Randomized Trial of Gastric and Transpyloric Feeds in Infants With Severe Bronchopulmonary Dysplasia
Bronchopulmonary dysplasia (BPD) is the most common complication of extreme preterm birth. It impacts 10,000-15,000 infants in the US annually, including approximately 50% of infants with birth weight < 1000g. BPD is associated with multiple long-term adverse outcomes including chronic cardiopulmonary and neurodevelopmental impairments. Infants with severe BPD, defined as a need for ≥ 30% inspired oxygen and/or mechanical respiratory support at 36 weeks postmenstrual age (PMA), suffer the greatest burden of these chronic sequelae. Recurrent episodes of hypoxemia and prolonged exposure to supplemental oxygen are linked to the development of these impairments. Gastroesophageal reflux (GER) contributes to these mechanisms by exacerbating pulmonary inflammation and inducing bronchospasm. Unfortunately, clinically available methods to diagnose GER in infants are unreliable. Moreover, acid suppressive agents are both ineffective and carry high risk of serious life-threatening morbidity. Simple transpyloric feeding has promise, but has not been evaluated in BPD.
This study will pilot N-of-1 trials to assess whether transpyloric feeds reduce airway complications of GER and and whether this methodology can aid in identifying individual infants with severe BPD who are likely to benefit from prolonged use of transpyloric feeds.
Read more
Aim 1. To determine for each enrolled infant with severe BPD whether transpyloric compared to gastric feeds reduce the number of daily intermittent hypoxemic events (primary outcome) and improve a validated BPD severity score (secondary outcome).
The investigators hypothesize that 80% percent of enrolled infants will have significantly fewer daily intermittent hypoxemic events with transpyloric compared to gastric feeds and will have this feeding method formally recommended.
Aim 2. To pool results from multiple N-of-1 trials to determine whether transpyloric compared to gastric feeds reduce airway complications of GER in infants with severe BPD.
The investigators hypothesize that transpyloric compared to gastric feeds will be associated overall with a 15% reduction in number of daily intermittent hypoxemic events.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- transpyloric feeding, gastric feeding
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transpyloric feedingOther
gastric feedingOther
| Study group | Role | What they receive |
|---|---|---|
| transpyloric tube feeds | Active comparator | Continuous transpyloric tube feeds administered through an oral/nasal feeding tube. Receives: Other: transpyloric feeding |
| gastric tube feeds | Active comparator | Continuous gastric tube feeds administered through an oral/nasal feeding tube. Receives: Other: gastric feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in transient intermittent hypoxemic events every 4 days
transient hypoxemic events is defined for the purposes of this study as an oxygen saturation < 80% for ≥ 10 seconds and < 3 minutes recorded by continuous pulse oximetry.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study start18 Dec 2014
- Primary completion15 Jul 2016
- Study completion15 Jul 2016
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 Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haresh Kirpalani, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142621
- Sponsor's protocol ID
- 14-010924
- Status last verified
- Feb 2018
- First submitted
- 15 May 2014
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jensen EA, Zhang H, Feng R, Dysart K, Nilan K, Munson DA, Kirpalani H. Individualising care in severe bronchopulmonary dysplasia: a series of N-of-1 trials comparing transpyloric and gastric feeding. Arch Dis Child Fetal Neonatal Ed. 2020 Jul;105(4):399-404. doi: 10.1136/archdischild-2019-317148. Epub 2019 Nov 4.
PubMed 31685527
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot N-of-1 Multiple Crossover Randomized Trial of Gastric and Transpyloric Feeds in Infants With Severe Bronchopulmonary Dysplasia
- ClinicalTrials.gov ID
- NCT02142621
- Acronym / sponsor ID
- 14-010924
- Conditions
- Bronchopulmonary Dysplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 18 Dec 2014 (actual)
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 15 Jul 2016 (actual)
- First posted
- 20 May 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.
Bronchopulmonary dysplasia (BPD) is the most common complication of extreme preterm birth. It impacts 10,000-15,000 infants in the US annually, including approximately 50% of infants with birth weight < 1000g. BPD is associated with multiple long-term adverse outcomes including chronic cardiopulmonary and neurodevelopmental impairments. Infants with severe BPD, defined as a need for ≥ 30% inspired oxygen and/or mechanical respiratory support at 36 weeks postmenstrual age (PMA), suffer the greatest burden of these chronic sequelae. Recurrent episodes of hypoxemia and prolonged exposure to supplemental oxygen are linked to the development of these impairments. Gastroesophageal reflux (GER) contributes to these mechanisms by exacerbating pulmonary inflammation and inducing bronchospasm. Unfortunately, clinically available methods to diagnose GER in infants are unreliable. Moreover, acid suppressive agents are both ineffective and carry high risk of serious life-threatening morbidity. Simple transpyloric feeding has promise, but has not been evaluated in BPD.
This study will pilot N-of-1 trials to assess whether transpyloric feeds reduce airway complications of GER and and whether this methodology can aid in identifying individual infants with severe BPD who are likely to benefit from prolonged use of transpyloric feeds.
Aim 1. To determine for each enrolled infant with severe BPD whether transpyloric compared to gastric feeds reduce the number of daily intermittent hypoxemic events (primary outcome) and improve a validated BPD severity score (secondary outcome).
The investigators hypothesize that 80% percent of enrolled infants will have significantly fewer daily intermittent hypoxemic events with transpyloric compared to gastric feeds and will have this feeding method formally recommended.
Aim 2. To pool results from multiple N-of-1 trials to determine whether transpyloric compared to gastric feeds reduce airway complications of GER in infants with severe BPD.
The investigators hypothesize that transpyloric compared to gastric feeds will be associated overall with a 15% reduction in number of daily intermittent hypoxemic events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transpyloric tube feeds | Active comparator | Other: transpyloric feedingContinuous transpyloric tube feeds administered through an oral/nasal feeding tube. |
| gastric tube feeds | Active comparator | Other: gastric feedingContinuous gastric tube feeds administered through an oral/nasal feeding tube. |
Who may qualify
- Ages
- 4 to 24 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age ≤ 32 weeks
- Severe BPD (FiO2 ≥ 30% and/or mechanical ventilation or non-invasive positive pressure respiratory support at the time of enrollment)
- Post menstrual age of 36-45 6/7 weeks at enrollment
- Parent and/or guardian permission (informed consent)
Key exclusion criteria (6 listed)
- Prior intolerance to transpyloric feeds
- History of surgical anti-reflux procedure
- Congenital heart disease (not including patent ductus arterioles and hemodynamically insignificant ventricular septal defect or atrial septal defect)
- Structural abnormalities of the upper airway, lungs, or chest wall
- Other congenital malformations or syndromes that adversely affect life expectancy or cardio-pulmonary development
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 |
|---|---|---|
| transpyloric feeding | Other | transpyloric tube feeds |
| gastric feeding | Other | gastric tube feeds |
Primary outcome
Change in transient intermittent hypoxemic events every 4 days
Time frame: 4 days
transient hypoxemic events is defined for the purposes of this study as an oxygen saturation < 80% for ≥ 10 seconds and < 3 minutes recorded by continuous pulse oximetry.
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 5 Feb 2018.
- Derived from this study: PubMed 31685527Jensen EA, Zhang H, Feng R, Dysart K, Nilan K, Munson DA, Kirpalani H. Individualising care in severe bronchopulmonary dysplasia: a series of N-of-1 trials comparing transpyloric and gastric feeding. Arch Dis Child Fetal Neonatal Ed. 2020 Jul;105(4):399-404. doi: 10.1136/archdischild-2019-317148. Epub 2019 Nov 4.
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BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
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Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
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Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
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Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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.
Haresh Kirpalani, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transpyloric feeding and gastric feeding in people with Bronchopulmonary Dysplasia, run by Children's Hospital of Philadelphia 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 4 inclusion and 6 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 5 Feb 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?
Change in transient intermittent hypoxemic events every 4 days (time frame: 4 days). 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 NCT02142621, 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 5 Feb 2018.