Prophylactic Versus Therapeutic Caffeine for Apnea of Prematurity

March 12, 2021 updated by: Nehad Nasef, Mansoura University Children Hospital
Investigators hypothesized that the timing of caffeine administration in either prophylaxis or treatment of apnea of prematurity will affect the apnea response to caffeine

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It will be a randomized control trial, patients will be randomly assigned to receive caffeine in a loading dose of 20 mg/kg (equivalent to 10 mg/kg caffeine base) and a maintenance dose of 10 mg/kg/day (equivalent to 5 mg/kg caffeine base) either as a prophylaxis group (1) or therapeutic group (2). Prophylactic caffeine (group 1) will be defined as caffeine prescribed for preterm infants within the first 72 hours of life prior to manifest apnea , therapeutic caffeine ( group 2 ) will be defined as caffeine prescribed for manifest apnea within or after the first 72 hours of life .

Preparation and administration of caffeine will be performed by a Neonatal intensive care unit (NICU) nurse.

Statistical Evaluation:

Statistical analyses will be performed with the Statistical Package for Social Sciences-SPSS version 16 software (SPSS Inc, Chicago, Illinois). For categorical variables, the X2 test will be used. For group comparisons, the Student T test will be used in normal distribution and the Mann-Whitney U test will be used in case of abnormal distribution.

For repeating measurements, variance analyses and Friedman variance analyses will be used. For descriptive statistics, percent, minimum-maximum-median, mean, and standard deviation will be used in accordance with the type and distribution of the variable. A P value <.05 was considered statistically significant. Informed consent will be obtained from parents, and the study will be approved by the local ethical committee.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El Dakahlya
      • Mansoura, El Dakahlya, Egypt, 35111
        • Mansoura University Children Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infants eligible for this study will be newborn infants ≤ 32 weeks with or without a diagnosis of apnea .

Exclusion Criteria:

  • Newborn infants with gestational age > 32 weeks.
  • Newborn infants with congenital malformations and chromosomal anomalies.
  • Newborn infants with apnea of other causes .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prophylactic caffeine citrate
Prophylactic caffeine (group1) will be defined as caffeine prescribed for preterm infant within the first 72 hours of life prior to manifest apnea . patients will be randomly assigned to receive caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base) .
Drug: Prophylactic caffeine citrate
Prophylactic caffeine (group1) will be defined as caffeine prescribed for preterm infant within the first 72 hours of life prior to manifest apnea . patients will be randomly assigned to receive caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base) .
Active Comparator: Therapeutic caffeine citrate
Therapeutic caffeine ( group 2 ) will be defined as caffeine prescribed for manifest apnea within or after the first 72 hours of life . patients will be randomly assigned to receive caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base).
Drug: Therapeutic caffeine citrate
Therapeutic caffeine ( group 2 ) will be defined as caffeine prescribed for manifest apnea within or after the first 72 hours of life . patients will be randomly assigned to receive caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of Respiratory Support
Time Frame: 60 days from NICU admission
60 days from NICU admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days of apnea free
Time Frame: 60 days from NICU admission
60 days from NICU admission
length of hospital stay
Time Frame: 60 days from NICU admission
60 days from NICU admission
Head ultrasound results
Time Frame: 14 days from NICU admission
Any grade of intraventricular hemorrhage (IVH); periventricular leukomalacia (PVL)
14 days from NICU admission
Necrotizing Enterocolitis
Time Frame: 30 days from NICU admission
Any stage, according to modified Bell classification
30 days from NICU admission
Retinopathy of prematurity
Time Frame: 60 days from NICU admission
Any stage, according to International classification of retinopathy of prematurity (ICROP)
60 days from NICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University Children Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

January 3, 2016

First Submitted That Met QC Criteria

February 8, 2016

First Posted (Estimate)

February 9, 2016

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 12, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R / 15.06.75

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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