Body WeightNCT02466620
A Comparison of Paediatric Weight Estimation Methods for Emergency Resuscitation
An observational study of Body Weight, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to study the validity, reliability and practicality of the different weight estimation methods (parent estimation method, Mercy method, Broselow tape, original and update APLS) in Thai children. Read more about this study
- Who is it for?
- Ages 6 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Weight
- How many people
- 430 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2015to Dec 2015
- Phase
- Observational
- 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 6 months to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 2 sources of study population: 1. Children from pre-school and primary school at Wat Amarintararam School, Bangkok, Thailand 2. Children from the out-patient department at Siriraj hospital, Bangkok, Thailand
Who may be able to join
- Healthy children
- Informed consent and assent (7-12 years) were obtained
Who cannot join
- Disabling children
- Incapable to stand up or lie down to measure weight or length
- Chronic steroid use
- Edema from known diseases
- Extremities joint contracture
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to study the validity, reliability and practicality of the different weight estimation methods (parent estimation method, Mercy method, Broselow tape, original and update APLS) in Thai children.
Read the detailed description
A reliable paediatric weight estimation method is crucial for the physician attempting to resuscitate an injured child. When a patient is in a critical, life threatening condition or in mass casualty settings, actual body weight cannot be obtained by weight measurement instrument. Several resuscitation modalities, such as resuscitation medications, fluid replacement, and amount of electrical shock in defibrillation, are calculated according to patient body weight
Besides from weight derived from children's parent which cannot achieve in some situations and vary in accuracy, Broselow tape is the gold standard currently for appraise children's weight from their length. However, this tape tends to underestimate weight and it is limited to use in children are less than 146 centimeters in length. Age- based weight estimation methods are the mathematical formulas to estimate weight from the children's age. The various methods described in the Advanced Paediatric Life support (APLS) both original and updated still have doubts about the accuracy and reliability. Both length- based and aged- based methods fail to resolve the overweight or obese and underweight children who have the same height or the same age. Mercy method is the new weight estimation method that incorporates the humeral length and mid-upper arm circumference to estimate the child weight. This method has been demonstrated both accuracy and reliability over other existing methods. This study will evaluate the validity, reliability and practicality of the previously mentioned pediatric weight estimation methods.
- Conditions
- Body Weight
- Keywords
- Body Weight, Resuscitation, Pediatric weight estimation
- Medical subject headings
- Body Weight
What is being measured
The primary outcome is the main question the study is designed to answer.
The validity of the different weight estimation methods
The performance of the Mercy method, Broselow tape, parental estimation and aged-base methods (original APLS,updated APLS formula) were compared against the actual weight and against each other. Agreement between estimated weight and actual weight of each weight estimation method was determined by Bland-Altman plots with 95% limits of agreement and correlation test. Bias and variability tested by calculate error : predicted weight -actual weight, calculated percentage error : [(predicted - actual weight) x 100%] / actual weight, calculated root mean square error = square root of the average squared error. Categorical error analysis was done by the percentage error of each of the estimation techniques within 10% and 20% of actual weight.
Measured: at time of measurement within one day
Secondary outcomes (2)
The reliability of the different weight estimation methods
The inter-rater reliability compared the results between two raters. The intra-rater reliability was compared the results from first and second measurement in one rater.The value was tested by intra- class correlation coefficient that a value > 0.8 was considered to excellent correlation.
Measured: at time of measurement within one day
The practicality of the different weight estimation methods
User satisfaction was evaluated from questionnaire and the values were analysed by descriptive statistics. Time from start measurement until get the estimated weight was recorded in all methods (except in parental estimation method) to calculate median time measurement.
Measured: at time of measurement within one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completionNov 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Body WeightStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Artid Samerchua, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466620
- Sponsor's protocol ID
- 719/2557(EC4)
- Status last verified
- Nov 2015
- First submitted
- 2 Jun 2015
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lundahl A, Kidwell KM, Nelson TD. Parental underestimates of child weight: a meta-analysis. Pediatrics. 2014 Mar;133(3):e689-703. doi: 10.1542/peds.2013-2690. Epub 2014 Feb 2.
PubMed 24488736Graves L, Chayen G, Peat J, O'Leary F. A comparison of actual to estimated weights in Australian children attending a tertiary children's' hospital, using the original and updated APLS, Luscombe and Owens, Best Guess formulae and the Broselow tape. Resuscitation. 2014 Mar;85(3):392-6. doi: 10.1016/j.resuscitation.2013.11.024. Epub 2013 Dec 7.
PubMed 24321321Dicko A, Alhousseini ML, Sidibe B, Traore M, Abdel-Rahman SM. Evaluation of the Mercy weight estimation method in Ouelessebougou, Mali. BMC Public Health. 2014 Mar 21;14:270. doi: 10.1186/1471-2458-14-270.
PubMed 24650051Abdel-Rahman SM, Ridge A, Kearns GL. Estimation of body weight in children in the absence of scales: a necessary measurement to insure accurate drug dosing. Arch Dis Child. 2014 Jun;99(6):570-4. doi: 10.1136/archdischild-2013-305211. Epub 2014 Feb 26. No abstract available.
PubMed 24573883Abdel-Rahman SM, Ahlers N, Holmes A, Wright K, Harris A, Weigel J, Hill T, Baird K, Michaels M, Kearns GL. Validation of an improved pediatric weight estimation strategy. J Pediatr Pharmacol Ther. 2013 Apr;18(2):112-21. doi: 10.5863/1551-6776-18.2.112.
PubMed 23798905Trakulsrichai S, Boonsri C, Chatchaipun P, Chunharas A. Accuracy of three methods used for Thai children's body weight estimation. J Med Assoc Thai. 2012 Sep;95(9):1194-9.
PubMed 23140037Loo PY, Chong SL, Lek N, Bautista D, Ng KC. Evaluation of three paediatric weight estimation methods in Singapore. J Paediatr Child Health. 2013 Apr;49(4):E311-6. doi: 10.1111/jpc.12141. Epub 2013 Mar 14.
PubMed 23489439Meguerdichian MJ, Clapper TC. The Broselow tape as an effective medication dosing instrument: a review of the literature. J Pediatr Nurs. 2012 Aug;27(4):416-20. doi: 10.1016/j.pedn.2012.04.009. Epub 2012 May 8. No abstract available.
PubMed 22579781
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Paediatric Weight Estimation Methods for Emergency Resuscitation
- ClinicalTrials.gov ID
- NCT02466620
- Acronym / sponsor ID
- 719/2557(EC4)
- Conditions
- Body Weight
- Keywords
- Body Weight, Resuscitation, Pediatric weight estimation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 9 Jun 2015 (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 study the validity, reliability and practicality of the different weight estimation methods (parent estimation method, Mercy method, Broselow tape, original and update APLS) in Thai children.
Detailed description
A reliable paediatric weight estimation method is crucial for the physician attempting to resuscitate an injured child. When a patient is in a critical, life threatening condition or in mass casualty settings, actual body weight cannot be obtained by weight measurement instrument. Several resuscitation modalities, such as resuscitation medications, fluid replacement, and amount of electrical shock in defibrillation, are calculated according to patient body weight
Besides from weight derived from children's parent which cannot achieve in some situations and vary in accuracy, Broselow tape is the gold standard currently for appraise children's weight from their length. However, this tape tends to underestimate weight and it is limited to use in children are less than 146 centimeters in length. Age- based weight estimation methods are the mathematical formulas to estimate weight from the children's age. The various methods described in the Advanced Paediatric Life support (APLS) both original and updated still have doubts about the accuracy and reliability. Both length- based and aged- based methods fail to resolve the overweight or obese and underweight children who have the same height or the same age. Mercy method is the new weight estimation method that incorporates the humeral length and mid-upper arm circumference to estimate the child weight. This method has been demonstrated both accuracy and reliability over other existing methods. This study will evaluate the validity, reliability and practicality of the previously mentioned pediatric weight estimation methods.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 2 sources of study population: 1. Children from pre-school and primary school at Wat Amarintararam School, Bangkok, Thailand 2. Children from the out-patient department at Siriraj hospital, Bangkok, Thailand
Key inclusion criteria (2 listed)
- Healthy children
- Informed consent and assent (7-12 years) were obtained
Key exclusion criteria (5 listed)
- Disabling children
- Incapable to stand up or lie down to measure weight or length
- Chronic steroid use
- Edema from known diseases
- Extremities joint contracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The validity of the different weight estimation methods
Time frame: at time of measurement within one day
The performance of the Mercy method, Broselow tape, parental estimation and aged-base methods (original APLS,updated APLS formula) were compared against the actual weight and against each other. Agreement between estimated weight and actual weight of each weight estimation method was determined by Bland-Altman plots with 95% limits of agreement and correlation test. Bias and variability tested by calculate error : predicted weight -actual weight, calculated percentage error : [(predicted - actual weight) x 100%] / actual weight, calculated root mean square error = square root of the average squared error. Categorical error analysis was done by the percentage error of each of the estimation techniques within 10% and 20% of actual weight.
2 secondary outcomes
The reliability of the different weight estimation methods
Time frame: at time of measurement within one day
The practicality of the different weight estimation methods
Time frame: at time of measurement within one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
- Background: PubMed 24488736Lundahl A, Kidwell KM, Nelson TD. Parental underestimates of child weight: a meta-analysis. Pediatrics. 2014 Mar;133(3):e689-703. doi: 10.1542/peds.2013-2690. Epub 2014 Feb 2.
- Background: PubMed 24321321Graves L, Chayen G, Peat J, O'Leary F. A comparison of actual to estimated weights in Australian children attending a tertiary children's' hospital, using the original and updated APLS, Luscombe and Owens, Best Guess formulae and the Broselow tape. Resuscitation. 2014 Mar;85(3):392-6. doi: 10.1016/j.resuscitation.2013.11.024. Epub 2013 Dec 7.
- Background: PubMed 24650051Dicko A, Alhousseini ML, Sidibe B, Traore M, Abdel-Rahman SM. Evaluation of the Mercy weight estimation method in Ouelessebougou, Mali. BMC Public Health. 2014 Mar 21;14:270. doi: 10.1186/1471-2458-14-270.
- Background: PubMed 24573883Abdel-Rahman SM, Ridge A, Kearns GL. Estimation of body weight in children in the absence of scales: a necessary measurement to insure accurate drug dosing. Arch Dis Child. 2014 Jun;99(6):570-4. doi: 10.1136/archdischild-2013-305211. Epub 2014 Feb 26. No abstract available.
- Background: PubMed 23798905Abdel-Rahman SM, Ahlers N, Holmes A, Wright K, Harris A, Weigel J, Hill T, Baird K, Michaels M, Kearns GL. Validation of an improved pediatric weight estimation strategy. J Pediatr Pharmacol Ther. 2013 Apr;18(2):112-21. doi: 10.5863/1551-6776-18.2.112.
- Background: PubMed 23140037Trakulsrichai S, Boonsri C, Chatchaipun P, Chunharas A. Accuracy of three methods used for Thai children's body weight estimation. J Med Assoc Thai. 2012 Sep;95(9):1194-9.
- Background: PubMed 23489439Loo PY, Chong SL, Lek N, Bautista D, Ng KC. Evaluation of three paediatric weight estimation methods in Singapore. J Paediatr Child Health. 2013 Apr;49(4):E311-6. doi: 10.1111/jpc.12141. Epub 2013 Mar 14.
- Background: PubMed 22579781Meguerdichian MJ, Clapper TC. The Broselow tape as an effective medication dosing instrument: a review of the literature. J Pediatr Nurs. 2012 Aug;27(4):416-20. doi: 10.1016/j.pedn.2012.04.009. Epub 2012 May 8. No abstract available.
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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.
Artid Samerchua principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Weight, run by Mahidol University at 1 site in Thailand.
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 5 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: status not confirmed, as of the sponsor's last update on 17 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 Thailand. 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?
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?
The validity of the different weight estimation methods (time frame: at time of measurement within one day). 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 NCT02466620, which also lists 8 linked publications.
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 17 Nov 2015; AzTrials last refreshed its copy on 6 Nov 2026.