Effect of Caffeine on Preterm Infants' Bone Mineral Content

Apnea of Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03084432
• Other study ID #: 16246
• Status: Completed
• Phase: N/A
• First received: March 10, 2017
• Last updated: March 14, 2017
• Start date: December 1, 2014
• Est. completion date: September 1, 2016

Study information

• Verified date: March 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 1, 2016
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea of Prematurity
• Bone Diseases, Metabolic
• Osteopenia (Disorder)

Intervention

Diagnostic Test:
• Dual Energy X-ray Absorptiometry
Dual Energy X-ray Absorptiometry done for both studied groups

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect of caffeine therapy on bone mineral content using Dual Energy X-ray Absorptiometry	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.	5-6 weeks