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Body WeightNCT02455674

Using Mean Ages on Clothing Size Labels in Revised Advanced Pediatric Life Support Formulas for Weight Estimation

An observational study of Body Weight, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Weight calculation based on age could be performed according to APLS (Advanced Pediatric Life Support) guideline recommendations in children requiring emergency treatment and intervention in the field or during resuscitation with no active weight and height measurements. Read more about this study

Who is it for?
Ages 1 year to 12 yearsHealthy volunteers can take part
Conditions the study is for
Body Weight
How many people
1,094 participants
Where
1 siteTurkey (Türkiye)
Study dates
Dec 2014to Jan 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 1 year to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Data of children, aged between 1 to 12 years, were consecutively collected. Patients were divided into two groups as under the age of 6 (age <6) and over 6 years of age (age≥6).

Who may be able to join

  • All patients between 1-12 years of age who presented to the emergency department and agreed to participate in the study were consecutively included in the study

Who cannot join

  • Age under 1 years and over 12.99 years
  • No weighing in ED
  • No clothing size label information
  • Refused to participate

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Antalya Training and Research Hospital, Department of Emergency

    Antalya, 07100

Other trials in Turkey (Türkiye)

About this study

Official title: Weight Estimation of A Child With Unknown Age and Height: Using Mean Ages on Clothing Size Labels in Revised APLS Formulas for Weight Estimation. A Prospective Cross-Sectional Study

Weight calculation based on age could be performed according to APLS (Advanced Pediatric Life Support) guideline recommendations in children requiring emergency treatment and intervention in the field or during resuscitation with no active weight and height measurements. The aim of the study is to investigate the suitability of weight calculation using mean ages on clothing size labels (ACL) to the actual weight in real emergencies with no known actual age of the patient (AA).

Read the detailed description

Weight calculation based on age could be performed according to APLS guideline recommendations in children requiring emergency treatment and intervention in the field or during resuscitation with no active weight and height measurements. Age formulas require only knowledge of the actual age of the child and widely used all over the world with being catchy. However, situations in which one has to intervene a child without having any patient data, including information on children's ages, especially in the field or during resuscitation are not uncommon. The objective of this study is to investigate the availability of age information contained in clothing size labels of children in weight calculation according to APLS recommendations. Usability of labels can protect victims from overdose and underdose problems in cases where the actual age is unknown and the measurements cannot be done

Conditions
Body Weight
Keywords
weight estimation, emergency, child
Medical subject headings
Body Weight, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02455674
Study groupRoleWhat they receive
Age under 6 yearsAll children 1 to 6 years Used formula for weight calculation: Children 1-5 years: Weight (kg) = (2 × age in years) + 8
Age over 6 yearsAll children 6 to 12 years Used formula for weight calculation: Children 6-12 years: Weight (kg) = (3 × age in years) + 7

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation of children's actual age and age information on clothing size labels.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionJan 2015
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
1,094 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02455674
Sponsor's protocol ID
AntalyaTRH003
Status last verified
May 2015
First submitted
21 May 2015
Last updated
28 May 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Young TP, Washington O, Flanery A, Guptill M, Reibling ET, Brown L, Barcega B. Comparison of the finger counting method, the Broselow tape and common weight estimation formulae in Filipino children after Typhoon Haiyan. Emerg Med Australas. 2015 Jun;27(3):239-44. doi: 10.1111/1742-6723.12382. Epub 2015 Mar 26.

    PubMed 25818595

  • 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.

    PubMed 24321321

  • Sanghera N, Chan PY, Khaki ZF, Planner C, Lee KK, Cranswick NE, Wong IC. Interventions of hospital pharmacists in improving drug therapy in children: a systematic literature review. Drug Saf. 2006;29(11):1031-47. doi: 10.2165/00002018-200629110-00003.

    PubMed 17061909

  • Wells M, Coovadia A, Kramer E, Goldstein L. The PAWPER tape: A new concept tape-based device that increases the accuracy of weight estimation in children through the inclusion of a modifier based on body habitus. Resuscitation. 2013 Feb;84(2):227-32. doi: 10.1016/j.resuscitation.2012.05.028. Epub 2012 Jul 13.

    PubMed 22796544

  • Argall JA, Wright N, Mackway-Jones K, Jackson R. A comparison of two commonly used methods of weight estimation. Arch Dis Child. 2003 Sep;88(9):789-90. doi: 10.1136/adc.88.9.789. No abstract available.

    PubMed 12937099

  • Kelly AM, Nguyen K, Krieser D. Validation of the Luscombe weight formula for estimating children's weight. Emerg Med Australas. 2011 Feb;23(1):59-62. doi: 10.1111/j.1742-6723.2010.01351.x. Epub 2010 Dec 6.

    PubMed 21134132

  • Luscombe MD, Owens BD, Burke D. Weight estimation in paediatrics: a comparison of the APLS formula and the formula 'Weight=3(age)+7'. Emerg Med J. 2011 Jul;28(7):590-3. doi: 10.1136/emj.2009.087288. Epub 2010 Jul 20.

    PubMed 20659877

  • Thompson MT, Reading MJ, Acworth JP. Best Guess method for age-based weight estimation in paediatric emergencies: validation and comparison with current methods. Emerg Med Australas. 2007 Dec;19(6):535-42. doi: 10.1111/j.1742-6723.2007.01031.x.

    PubMed 18021106

  • van Furth R, Braat AG, Leijh PC, Klein F. Opsonic activity and composition of five intramuscular gammaglobulin preparations. J Infect. 1986 Nov;13(3):269-75. doi: 10.1016/s0163-4453(86)91256-9.

    PubMed 2432132

  • Sinha M, Lezine MW, Frechette A, Foster KN. Weighing the pediatric patient during trauma resuscitation and its concordance with estimated weight using Broselow Luten Emergency Tape. Pediatr Emerg Care. 2012 Jun;28(6):544-7. doi: 10.1097/PEC.0b013e318258ac2e.

    PubMed 22653453

  • Lim CA, Kaufman BJ, O'Connor J Jr, Cunningham SJ. Accuracy of weight estimates in pediatric patients by prehospital Emergency Medical Services personnel. Am J Emerg Med. 2013 Jul;31(7):1108-12. doi: 10.1016/j.ajem.2013.04.018. Epub 2013 May 21.

    PubMed 23706580

  • Elgie LD, Williams AR. Using age on clothes size label to estimate weight in emergency paediatric patients. Eur J Emerg Med. 2012 Oct;19(5):338-40. doi: 10.1097/MEJ.0b013e328355abc2.

    PubMed 22914117

  • Krieser D, Nguyen K, Kerr D, Jolley D, Clooney M, Kelly AM. Parental weight estimation of their child's weight is more accurate than other weight estimation methods for determining children's weight in an emergency department? Emerg Med J. 2007 Nov;24(11):756-9. doi: 10.1136/emj.2007.047993.

    PubMed 17954827

  • Leffler S, Hayes M. Analysis of parental estimates of children's weights in the ED. Ann Emerg Med. 1997 Aug;30(2):167-70. doi: 10.1016/s0196-0644(97)70137-9.

    PubMed 9250640

  • Rosenberg M, Greenberger S, Rawal A, Latimer-Pierson J, Thundiyil J. Comparison of Broselow tape measurements versus physician estimations of pediatric weights. Am J Emerg Med. 2011 Jun;29(5):482-8. doi: 10.1016/j.ajem.2009.12.002. Epub 2010 Apr 2.

    PubMed 20825816

Questions about this trial

What is this clinical trial studying?

An observational study of Body Weight, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).

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 1 inclusion and 4 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 28 May 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 Turkey (Türkiye). 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?

Correlation of children's actual age and age information on clothing size labels. (time frame: 6 weeks). 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 NCT02455674, which also lists 19 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 28 May 2015.

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