Newborn MorbidityNCT03350022
Sham Feeding Post-operative Infants
A study of Newborn Morbidity and Oral Aversion, run by Le Bonheur Children's Hospital at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate a feeding technique, sham feeding, to promote adequate oral skills in order to prevent oral aversion and/or poor oral skills due to the delay in oral feeds for surgical reasons. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Newborn Morbidity, Oral Aversion, Gastroschisis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2018to 4 Sep 2019
- 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 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates at least 34 weeks post-menstrual age who have a history of gastrointestinal surgery, require no respiratory support more than 2 lpm by nasal cannula, and have an anticipated prolonged course with contraindication to normal oral or enteral feeding. They must have a diagnosis of gastroschisis awaiting return of bowel function, bowel atresia or other obstruction with anticipated feeding contraindication longer than 30 days, or short bowel syndrome intolerant of full intermittent oral feeding.
- Mothers of enrolled neonates
Who cannot join
- Lack of consent or parental consent.
- Contraindication to sham feeding as determined by the responsible medical provider.
Trial locations and contacts
1 site in 1 country.
United States1 site
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
About this study
Official title: Pilot Study on Sham Feeding in Post-operative Gastrointestinal Surgery Infants
The purpose of this pilot study is to evaluate a feeding technique, sham feeding, to promote adequate oral skills in order to prevent oral aversion and/or poor oral skills due to the delay in oral feeds for surgical reasons. Sham feeding is intended for infants who are expected to have a prolonged course without normal enteral feeding by mouth.
Read the detailed description
There is a lack of literature and research on which to base interventions that intend to preserve and develop oral and motor feeding skills in the post-operative patient population during the critical window of opportunity to establish proper oral skills. Due to the lack of positive oral feeding stimuli (i.e. prolonged airway management, nasogastric tubes, and airway and upper GI suctioning), these patients are at risk to develop oral aversions that may negatively impact long-term outcomes.
Parents in the neonatal intensive care unit (NICU) report feelings of stress and loss of control associated with medical interventions. When normal oral feeding is contraindicated, there may be impairment of parent-child bonding and mothers may be less dedicated to providing milk for the infant. Impaired bonding has been shown to affect the parent-child relationship and the child's development long after discharge.
Sham feeding has been shown to be safe and shorten time to oral feeding in infants with esophageal atresia with delayed esophageal repair. Anecdotal evidence from Le Bonheur suggests that sham feeding in post-operative gastroschisis patients improves parental satisfaction and engagement.
There is no literature to describe the use of sham feeding in neonates other than those with esophageal atresia. Anecdotal reports from our institution and others institutions suggests that it increases parental engagement and improves parental satisfaction among patients with other bowel pathology.
This is a cohort study with historical controls within a single level IV NICU. Participants will be offered sham feeding by breast or bottle and observed.
- Being tested
- Sham Feeding
- Medical subject headings
- Gastroschisis, Intestinal Obstruction, Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham FeedingProcedure or surgery
Also called Observation
Sham feeding will be offered to participants.
| Study group | Role | What they receive |
|---|---|---|
| Sham Feeding | Experimental | Not described Receives: Procedure: Sham Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to full feeds
Time to full oral feeds after resolution of feeding contraindications
Measured: 1 year
Secondary outcomes (3)
Growth
Infant growth parameters
Measured: 1 year
Duration of breast feeding
Duration of breast feeding or pumping of mother's milk
Measured: 1 year
Maternal satisfaction
Maternal satisfaction survey after intervention
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start10 Jan 2018
- Primary completion4 Sep 2019
- Study completion4 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn MorbidityStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Le Bonheur Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Weems, MD, Le Bonheur Children's Hospital
- Investigators
- Mark Weems, MD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350022
- Sponsor's protocol ID
- 17-05475-FB
- Status last verified
- Feb 2020
- First submitted
- 17 Nov 2017
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Sham Feeding in Post-operative Gastrointestinal Surgery Infants
- ClinicalTrials.gov ID
- NCT03350022
- Acronym / sponsor ID
- 17-05475-FB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Le Bonheur Children's HospitalUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 4 Sep 2019 (actual)
- Study completion
- 4 Sep 2019 (actual)
- First posted
- 22 Nov 2017 (actual)
- 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 this pilot study is to evaluate a feeding technique, sham feeding, to promote adequate oral skills in order to prevent oral aversion and/or poor oral skills due to the delay in oral feeds for surgical reasons. Sham feeding is intended for infants who are expected to have a prolonged course without normal enteral feeding by mouth.
Detailed description
There is a lack of literature and research on which to base interventions that intend to preserve and develop oral and motor feeding skills in the post-operative patient population during the critical window of opportunity to establish proper oral skills. Due to the lack of positive oral feeding stimuli (i.e. prolonged airway management, nasogastric tubes, and airway and upper GI suctioning), these patients are at risk to develop oral aversions that may negatively impact long-term outcomes.
Parents in the neonatal intensive care unit (NICU) report feelings of stress and loss of control associated with medical interventions. When normal oral feeding is contraindicated, there may be impairment of parent-child bonding and mothers may be less dedicated to providing milk for the infant. Impaired bonding has been shown to affect the parent-child relationship and the child's development long after discharge.
Sham feeding has been shown to be safe and shorten time to oral feeding in infants with esophageal atresia with delayed esophageal repair. Anecdotal evidence from Le Bonheur suggests that sham feeding in post-operative gastroschisis patients improves parental satisfaction and engagement.
There is no literature to describe the use of sham feeding in neonates other than those with esophageal atresia. Anecdotal reports from our institution and others institutions suggests that it increases parental engagement and improves parental satisfaction among patients with other bowel pathology.
This is a cohort study with historical controls within a single level IV NICU. Participants will be offered sham feeding by breast or bottle and observed.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sham Feeding | Experimental | Procedure: Sham Feeding |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Neonates at least 34 weeks post-menstrual age who have a history of gastrointestinal surgery, require no respiratory support more than 2 lpm by nasal cannula, and have an anticipated prolonged course with contraindication to normal oral or enteral feeding. They must have a diagnosis of gastroschisis awaiting return of bowel function, bowel atresia or other obstruction with anticipated feeding contraindication longer than 30 days, or short bowel syndrome intolerant of full intermittent oral feeding.
- Mothers of enrolled neonates
Key exclusion criteria (2 listed)
- Lack of consent or parental consent.
- Contraindication to sham feeding as determined by the responsible medical provider.
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 |
|---|---|---|
| Sham FeedingAlso: ObservationSham feeding will be offered to participants. | Procedure or surgery | Sham Feeding |
Primary outcome
Time to full feeds
Time frame: 1 year
Time to full oral feeds after resolution of feeding contraindications
3 secondary outcomes
Growth
Time frame: 1 year
Duration of breast feeding
Time frame: 1 year
Maternal satisfaction
Time frame: 1 year
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 20 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Mark Weems, MD principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Newborn Morbidity and Oral Aversion, run by Le Bonheur Children's Hospital 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 2 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 20 Feb 2020. 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?
Time to full feeds (time frame: 1 year). 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 20 Feb 2020.