Enteral Tube PlacementPhase 2NCT01407991
Nasogastric/Oral Gastric Tube Placement in Infants: Comparing 2 Measurement Methods
A Phase 2 study testing enteral tube placement accuracy and NEM method for NG/OG tube placement in people with Enteral Tube Placement, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The purpose of this study is to compare two methods of nasogastric/oral gastric (NG/OG) tube placement for efficacy and safety in the placement of NG/OG tube in infants less than 6 months of age. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Enteral Tube Placement
- What is being tested?
- enteral tube placement accuracy and NEM method for NG/OG tube placement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Nov 2015
- Phase
- Phase 2
- 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 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants less than 6 months of age in the neonatal intensive care unit (NICU) regardless of gestational age
- Infants requiring an NG or OG tube for enteral feeds
- Infants whose NG tube is placed by the bedside Registered Nurse (RN)
- Parents need to speak and read English
- Infant scheduled for X-Ray for standard of care (SOC) within 24hrs of scheduled NG/OG tube change or placement.
Who cannot join
- Infants with congenital or structural anomalies of the GI tract
- Infants with significant scoliosis
- Infants with salem sump or repogle tube
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: Placement of NG or OG Tube in Infants by Length Versus Traditional Measuring Methods
The purpose of this study is to compare two methods of nasogastric/oral gastric (NG/OG) tube placement for efficacy and safety in the placement of NG/OG tube in infants less than 6 months of age. One method is based on the infant's length determined by measurement using a length board and plotted on a graph derived from a formula to determine the depth for tube insertion (graph method) and the other method is based on current standard of care, measuring from the nose to the ear and then the ear to mid abdomen (NEM) and mark the tube to know how far to insert the tube. Outcome comparison will be xray verification of placement.
Read the detailed description
Preterm infants often require nutritional intake through a nasogastric or oral gastric tube to meet their high energy requirement and avoid aspiration of nutrition due to their immature suck/swallow reflex. When providing nutrition via an NG or OG tube, there are two basic safety issues; accurate placement, determined by the end of the tube reaching the mid abdominal area, and verification methods to assure placement is optimal. Based on a review of relevant literature, a potentially more accurate method of tube placement is available than the method used in current practice. We hypothesize the graph method will result in a more accurate and less variable placement of the NG tube into the mid-stomach of preterm infants than the current standard using the NEM method.
- Conditions
- Enteral Tube Placement
- Being tested
- enteral tube placement accuracy, NEM method for NG/OG tube placement
- Keywords
- Enteral tube placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enteral tube placement accuracyOther
The graph method is based on the infants' length determined by measurement using a length board and plotted on a graph derived from a formula to determine the depth for tube insertion (graph method). The graph method has been tested in the pediatric population but not in infants under six months of age (Klazner, Luke and Scalso, 2002). Using a graph method might reduce some of the variability in placement. We propose to extend the Klazner, Luke and Scalso (2002) study in the infant population.
NEM method for NG/OG tube placementOther
measure distance from the mouth to the ear and then the ear to mid abdomen and mark the tube to insert to that length
| Study group | Role | What they receive |
|---|---|---|
| Length or graph method | Experimental | The graph method is based on the infants' length determined by measurement using a length board and plotted on a graph derived from a formula to determine the depth for tube insertion (graph method). The graph method has been tested in the pediatric population but not in infants under six months of age (Klazner, Luke and Scalso, 2002). Using a graph method might reduce some of the variability in placement. We propose to extend the Klazner, Luke and Scalso (2002) study in the infant population. Receives: Other: enteral tube placement accuracy |
| NEM method for NG/OG tube placement | Active comparator | Standard method- measure distance from the mouth to the ear and then the ear to mid abdomen and mark the tube to insert to that length. Nose to ear to mid-xiphoid-umbilicus (NEM). Receives: Other: NEM method for NG/OG tube placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety and efficacy of Nasogastric/Orogastric tube placement using the length method
During the same day of NG/OG tube placement, verification of placement will be performed by bedside nurse as per institutional standards. X-ray verification will be done in batches (not same day) and read by radiologist blind to insertion method.
Measured: Participants will be followed for the duration of hospitalization, an average expected time of 4 weeks. Once an OG/NG tube change is completed per study protocol the participant will have completed the study.
Secondary outcomes (1)
compare depth ( too high, center, or too low) of NG/OG tube between the length method and the NEM method
Radiologist blinded to the randomized method of insertion will determine location of placement.
Measured: X-ray outcome of NG/OG placement will be measured after every 10 subjects complete the study, on average 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Study terminated due to change in clinical practice affecting recruitment. For majority of patients, NJ tubes are now used instead of NG tubes.
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 Enteral Tube PlacementStudies 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Ely, PhD, RN, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407991
- Sponsor's protocol ID
- 10-007863
- Status last verified
- Nov 2015
- First submitted
- 25 Jul 2011
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Klasner AE, Luke DA, Scalzo AJ. Pediatric orogastric and nasogastric tubes: a new formula evaluated. Ann Emerg Med. 2002 Mar;39(3):268-72. doi: 10.1067/mem.2002.120124.
PubMed 11867979
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placement of NG or OG Tube in Infants by Length Versus Traditional Measuring Methods
- ClinicalTrials.gov ID
- NCT01407991
- Acronym / sponsor ID
- 10-007863
- Conditions
- Enteral Tube Placement
- Keywords
- Enteral tube placement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to change in clinical practice affecting recruitment. For majority of patients, NJ tubes are now used instead of NG tubes.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 2 Aug 2011 (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 this study is to compare two methods of nasogastric/oral gastric (NG/OG) tube placement for efficacy and safety in the placement of NG/OG tube in infants less than 6 months of age. One method is based on the infant's length determined by measurement using a length board and plotted on a graph derived from a formula to determine the depth for tube insertion (graph method) and the other method is based on current standard of care, measuring from the nose to the ear and then the ear to mid abdomen (NEM) and mark the tube to know how far to insert the tube. Outcome comparison will be xray verification of placement.
Detailed description
Preterm infants often require nutritional intake through a nasogastric or oral gastric tube to meet their high energy requirement and avoid aspiration of nutrition due to their immature suck/swallow reflex. When providing nutrition via an NG or OG tube, there are two basic safety issues; accurate placement, determined by the end of the tube reaching the mid abdominal area, and verification methods to assure placement is optimal. Based on a review of relevant literature, a potentially more accurate method of tube placement is available than the method used in current practice. We hypothesize the graph method will result in a more accurate and less variable placement of the NG tube into the mid-stomach of preterm infants than the current standard using the NEM method.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Length or graph method | Experimental | Other: enteral tube placement accuracyThe graph method is based on the infants' length determined by measurement using a length board and plotted on a graph derived from a formula to determine the depth for tube insertion (graph method). The graph method has been tested in the pediatric population but not in infants under six months of age (Klazner, Luke and Scalso, 2002). Using a graph method might reduce some of the variability in placement. We propose to extend the Klazner, Luke and Scalso (2002) study in the infant population. |
| NEM method for NG/OG tube placement | Active comparator | Other: NEM method for NG/OG tube placementStandard method- measure distance from the mouth to the ear and then the ear to mid abdomen and mark the tube to insert to that length. Nose to ear to mid-xiphoid-umbilicus (NEM). |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants less than 6 months of age in the neonatal intensive care unit (NICU) regardless of gestational age
- Infants requiring an NG or OG tube for enteral feeds
- Infants whose NG tube is placed by the bedside Registered Nurse (RN)
- Parents need to speak and read English
- Infant scheduled for X-Ray for standard of care (SOC) within 24hrs of scheduled NG/OG tube change or placement.
Key exclusion criteria (3 listed)
- Infants with congenital or structural anomalies of the GI tract
- Infants with significant scoliosis
- Infants with salem sump or repogle tube
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 |
|---|---|---|
| enteral tube placement accuracyThe graph method is based on the infants' length determined by measurement using a length board and plotted on a graph derived from a formula to determine the depth for tube insertion (graph method). The graph method has been tested in the pediatric population but not in infants under six months of age (Klazner, Luke and Scalso, 2002). Using a graph method might reduce some of the variability in placement. We propose to extend the Klazner, Luke and Scalso (2002) study in the infant population. | Other | Length or graph method |
| NEM method for NG/OG tube placementmeasure distance from the mouth to the ear and then the ear to mid abdomen and mark the tube to insert to that length | Other | NEM method for NG/OG tube placement |
Primary outcome
Evaluate safety and efficacy of Nasogastric/Orogastric tube placement using the length method
Time frame: Participants will be followed for the duration of hospitalization, an average expected time of 4 weeks. Once an OG/NG tube change is completed per study protocol the participant will have completed the study.
During the same day of NG/OG tube placement, verification of placement will be performed by bedside nurse as per institutional standards. X-ray verification will be done in batches (not same day) and read by radiologist blind to insertion method.
1 secondary outcome
compare depth ( too high, center, or too low) of NG/OG tube between the length method and the NEM method
Time frame: X-ray outcome of NG/OG placement will be measured after every 10 subjects complete the study, on average 4 weeks.
Results and safety
The study was stopped early (reason given: Study terminated due to change in clinical practice affecting recruitment. For majority of patients, NJ tubes are now used instead of NG tubes.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
- Results publication: PubMed 11867979Klasner AE, Luke DA, Scalzo AJ. Pediatric orogastric and nasogastric tubes: a new formula evaluated. Ann Emerg Med. 2002 Mar;39(3):268-72. doi: 10.1067/mem.2002.120124.
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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.
Elizabeth Ely, PhD, RN 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 Phase 2 study testing enteral tube placement accuracy and NEM method for NG/OG tube placement in people with Enteral Tube Placement, 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 10 Nov 2015. 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 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.
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 was stopped early (reason given: Study terminated due to change in clinical practice affecting recruitment. For majority of patients, NJ tubes are now used instead of NG tubes.). Results are not available in the source record.
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?
Evaluate safety and efficacy of Nasogastric/Orogastric tube placement using the length method (time frame: Participants will be followed for the duration of hospitalization, an average expected time of 4 weeks. Once an OG/NG tube change is completed per study protocol the participant will have completed the study.). 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 NCT01407991, 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 10 Nov 2015.