Effect of Caffeine on Preterm Infants' Bone Mineral Content

NCT ID: NCT03084432

Last Updated: 2017-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-01

Study Completion Date

2016-09-01

Brief Summary

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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

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Conditions

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Osteopenia (Disorder) Apnea of Prematurity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Dual Energy X-ray Absorptiometry

Intervention Type DIAGNOSTIC_TEST

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

Dual Energy X-ray Absorptiometry

Intervention Type DIAGNOSTIC_TEST

Dual Energy X-ray Absorptiometry done for both studied groups

Interventions

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Dual Energy X-ray Absorptiometry

Dual Energy X-ray Absorptiometry done for both studied groups

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Rania Ismail

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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16246

Identifier Type: -

Identifier Source: org_study_id

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