Effect of Caffeine on Preterm Infants' Bone Mineral Content

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

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.

Study Overview

• Status: Completed
• Conditions: Apnea of Prematurity; Osteopenia (Disorder)
• Intervention / Treatment: Diagnostic test: Dual Energy X-ray Absorptiometry

• Study Type: Observational
• Enrollment (Actual): 42

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

preterm neonates

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
caffeine group; 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	Diagnostic test: Dual Energy X-ray Absorptiometry; Dual Energy X-ray Absorptiometry done for both studied groups
control group; 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	Diagnostic test: Dual Energy X-ray Absorptiometry; Dual Energy X-ray Absorptiometry done for both studied groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2014
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (ACTUAL): March 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: caffeine; bone mineral content
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: 16246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No