Effect of Caffeine on Preterm Infants' Bone Mineral Content

The primary objective was to determine whether caffeine therapy is associated with decreases bone mineral content using dual energy x-ray absorptiometry. Secondary objectives were to determine whether caffeine therapy is associated with increased incidence of nephrocalcinosis or bone fracture.

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Key information

Conditions

Osteopenia (Disorder) Apnea Apnea of Prematurity Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Preterm infants with gestational age of 34 weeks or less consecutively admitted to the neonatal intensive care unit

Exclusion criteria

Renal or endocrinal diseases Congenital anomalies Suspected chromosomal aberrations Receiving diuretics or steroid therapy

Treatment and study plan

Dual Energy X-ray Absorptiometry

Diagnostic Test

Dual Energy X-ray Absorptiometry done for both studied groups

Primary outcomes

effect of caffeine therapy on bone mineral content using Dual Energy X-ray Absorptiometry

Time frame: 5-6 weeks

Whole Body Scanner, Pencil beam, regions: antro-posterior Spine, Lateral, Hip, Forearm/ Hand, Ortho Femur Speed: Up To 76mm Per Sec., Scan Times (min): antro-posterior Spine-2, Lateral-12, Hip-4, Forearm-1, Femur-4 Pentium II Computer System, Windows O/S, Lunar Software 15" Hi-Resolution Monitor, Auto Centering Laser Guide, Data Analysis: Auto Analysis Software, Smart Scan, Auto Position. Weight and length were measured and recorded. During the scan an infant was placed on the scanning table with the head at the marked start line, assuring that the position was the same for all subjects. The study was carried out with the infants sleeping without sedation. The infants were placed supine and were restrained with a cotton blanket. To induce sleep, infants were fed a few minutes prior to the study. When image quality was poor due to movement of the infant or to other causes the measurement at that time point was not included for analysis.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Assessment of Bone Mineral Content for Preterm Neonates Treated With Caffeine Using Dual Energy X-ray Absorptiometry : an Observational Study

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Mar 21, 2017
Registry last updated: Mar 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed