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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02466620
Other study ID # 719/2557(EC4)
Secondary ID
Status Active, not recruiting
Phase N/A
First received June 2, 2015
Last updated November 15, 2015
Start date February 2015
Est. completion date December 2015

Study information

Verified date November 2015
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 430
Est. completion date December 2015
Est. primary completion date November 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 12 Years
Eligibility Inclusion Criteria:

- Healthy children

- Informed consent and assent (7-12 years) were obtained

Exclusion Criteria:

- Disabling children

- Incapable to stand up or lie down to measure weight or length

- Chronic steroid use

- Edema from known diseases

- Extremities joint contracture

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Thailand Artid Samerchua Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (8)

Abdel-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. — View Citation

Abdel-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. — View Citation

Dicko A, Alhousseini ML, Sidibé B, Traoré 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. — View Citation

Graves 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. — View Citation

Loo 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. — View Citation

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. Review. — View Citation

Meguerdichian 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. Review. — View Citation

Trakulsrichai 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. at time of measurement within one day
Secondary 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. at time of measurement within one day
Secondary 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. at time of measurement within one day
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