Effect of Caffeine on Preterm Infants' Bone Mineral Content

Completed

• Conditions: Osteopenia (Disorder); Apnea of Prematurity
• Interventions: Diagnostic Test: Dual Energy X-ray Absorptiometry

• Registration Number: NCT03084432
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-01
• Primary Completion: 2016-06-01
• Study Completion: 2016-09-01
• Status Verified: 2017-03
• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-03-14
• Last Update Submitted: 2017-03-14
• Study First Posted: 2017-03-21
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	Dual Energy X-ray Absorptiometry	20 preterm infants for whom caffeine was not given, either it was not indicated, not available or parents refused its use.Dual Energy X-ray Absorptiometry was done 5th-6th week post-natal age
caffeine group	Dual Energy X-ray Absorptiometry	22 preterm infants received caffeine (starting from day 2 of life and received for more than 7 days) for apnea prophylaxis or treatment according to protocol of Ain Shams University neonatal intensive care unit \[apnea prophylaxis for preterm ≤32 weeks gestation and apnea treatment for those 33 or 34 weeks gestation\]. Dual Energy X-ray Absorptiometry was done 5th-6th week post-natal age

Primary Outcome Measures

Name	Time	Method
effect of caffeine therapy on bone mineral content using Dual Energy X-ray Absorptiometry	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.