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Apnea of PrematurityNCT02293824

Effect of Feedings on Caffeine in Premature Infants

An observational study of Apnea of Prematurity and Premature Newborn, run by Duke University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Almost all infants born <29 weeks gestational age develop apnea of prematurity and are treated with caffeine. Type of diet and disease states may be significant contributors of variability in caffeine metabolism and pharmacokinetics (PK) in this population. Read more about this study

Who is it for?
Ages Up to 15 days
Conditions the study is for
Apnea of Prematurity, Premature Newborn, Caffeine
What is being tested?
Caffeine
How many people
50 participants
Where
2 sitesUnited States
Study dates
Dec 2014to 30 Jun 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 15 days
  • All sexes
  • No healthy volunteers
  • Child

Study population: Premature infants given caffeine for the prevention or treatment of apnea of prematurity.

Who may be able to join

  • Written informed consent from parent(s) or legal guardian(s)
  • <29 weeks birth gestational age
  • Postnatal age ≤15 days
  • Receiving caffeine (intravenous or oral) per standard of care for prevention or treatment of apnea of prematurity

Who cannot join

  • Known major congenital or chromosomal anomaly

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • North Carolina Children's Hospital

    Chapel Hill, North Carolina, 27599

  • Duke University Medical Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Effect of Feedings on Caffeine Pharmacokinetics and Metabolism in Premature Infants

Almost all infants born <29 weeks gestational age develop apnea of prematurity and are treated with caffeine. Type of diet and disease states may be significant contributors of variability in caffeine metabolism and pharmacokinetics (PK) in this population. This prospective, observational, open-label, opportunistic PK study will compare the population PK of caffeine between infants fed formula and infants fed exclusively breast milk; compare the activities of caffeine metabolizing enzymes between infants fed formula and infants fed exclusively breast milk; and determine the effect of hypoxia, hypotension, and infection on caffeine PK and metabolism in premature infants.

Read the detailed description

This study will use a consecutive patient sampling approach. All eligible participants admitted at each site will be approached. Caffeine and feedings will be administered per standard of care. Manipulations of caffeine dosing or feeding regimens will not be a part of this protocol. To minimize the amount of blood sampling, the investigators will use a sparse sampling methodology. Urine will be collected for analysis of caffeine and caffeine metabolite concentrations. Caffeine pharmacokinetics will be described by population pharmacokinetic analysis. Urinary concentrations of caffeine and its metabolites will be used to calculate metabolic ratios as markers of enzyme activity.

Being tested
Caffeine
Keywords
Infant, Premature, Caffeine, Pharmacokinetics, Metabolism
Medical subject headings
Apnea, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CaffeineDrug

    Also called Caffeine Citrate, Cafcit

    Given per standard of care.

Study groups in NCT02293824
Study groupRoleWhat they receive
Premature infantsPremature infants <29 weeks birth gestational age receiving caffeine per standard of care for the prevention or treatment of apnea of prematurity.
Receives: Drug: Caffeine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clearance (CL) of caffeine at steady state

    Using population pharmacokinetic analyses

    Measured: Study days 0, 15, 30, 45, and 60.

Secondary outcomes (3)

  1. Volume of distribution (V) of caffeine at steady state

    Using population pharmacokinetic analyses

    Measured: Study days 0, 15, 30, 45, and 60

  2. Caffeine metabolizing enzyme activity using urinary metabolic ratios

    Activity levels of CYP1A2, xanthine oxidase, and N-acetyltransferase 2

    Measured: Study days 0, 15, 30, 45, and 60

  3. Fold change in caffeine clearance due to hypoxia, hypotension, and infections

    Effect of hypoxia, hypotension, and infections on caffeine clearance

    Measured: Study days 0, 15, 30, 45, and 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2014 (estimated)
  2. Study startDec 2014
  3. Primary completion30 Jun 2017
  4. Study completion30 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02293824
Sponsor's protocol ID
Pro00058253
Status last verified
Jun 2017
First submitted
14 Nov 2014
Last updated
13 Sep 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided: Will consider on a case-by-case basis (de-identified data only)

Publications

  • Zhao J, Gonzalez F, Mu D. Apnea of prematurity: from cause to treatment. Eur J Pediatr. 2011 Sep;170(9):1097-105. doi: 10.1007/s00431-011-1409-6. Epub 2011 Feb 8.

    PubMed 21301866

  • Di Fiore JM, Bloom JN, Orge F, Schutt A, Schluchter M, Cheruvu VK, Walsh M, Finer N, Martin RJ. A higher incidence of intermittent hypoxemic episodes is associated with severe retinopathy of prematurity. J Pediatr. 2010 Jul;157(1):69-73. doi: 10.1016/j.jpeds.2010.01.046. Epub 2010 Mar 20.

    PubMed 20304417

  • Janvier A, Khairy M, Kokkotis A, Cormier C, Messmer D, Barrington KJ. Apnea is associated with neurodevelopmental impairment in very low birth weight infants. J Perinatol. 2004 Dec;24(12):763-8. doi: 10.1038/sj.jp.7211182.

    PubMed 15329741

  • Clark RH, Bloom BT, Spitzer AR, Gerstmann DR. Reported medication use in the neonatal intensive care unit: data from a large national data set. Pediatrics. 2006 Jun;117(6):1979-87. doi: 10.1542/peds.2005-1707.

    PubMed 16740839

  • Gal P. Caffeine Therapeutic Drug Monitoring Is Necessary and Cost-effective. J Pediatr Pharmacol Ther. 2007 Oct;12(4):212-5. doi: 10.5863/1551-6776-12.4.212. No abstract available.

    PubMed 23055855

  • Blake MJ, Abdel-Rahman SM, Pearce RE, Leeder JS, Kearns GL. Effect of diet on the development of drug metabolism by cytochrome P-450 enzymes in healthy infants. Pediatr Res. 2006 Dec;60(6):717-23. doi: 10.1203/01.pdr.0000245909.74166.00. Epub 2006 Oct 25.

    PubMed 17065585

  • Le Guennec JC, Billon B. Delay in caffeine elimination in breast-fed infants. Pediatrics. 1987 Feb;79(2):264-8.

    PubMed 3808800

  • Xu H, Rajesan R, Harper P, Kim RB, Lonnerdal B, Yang M, Uematsu S, Hutson J, Watson-MacDonell J, Ito S. Induction of cytochrome P450 1A by cow milk-based formula: a comparative study between human milk and formula. Br J Pharmacol. 2005 Sep;146(2):296-305. doi: 10.1038/sj.bjp.0706319.

    PubMed 15997229

  • Supnet MC, David-Cu R, Walther FJ. Plasma xanthine oxidase activity and lipid hydroperoxide levels in preterm infants. Pediatr Res. 1994 Sep;36(3):283-7. doi: 10.1203/00006450-199409000-00003.

    PubMed 7808822

  • Hassoun PM, Yu FS, Cote CG, Zulueta JJ, Sawhney R, Skinner KA, Skinner HB, Parks DA, Lanzillo JJ. Upregulation of xanthine oxidase by lipopolysaccharide, interleukin-1, and hypoxia. Role in acute lung injury. Am J Respir Crit Care Med. 1998 Jul;158(1):299-305. doi: 10.1164/ajrccm.158.1.9709116.

    PubMed 9655743

Questions about this trial

What is this clinical trial studying?

An observational study of Apnea of Prematurity and Premature Newborn, run by Duke University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clearance (CL) of caffeine at steady state (time frame: Study days 0, 15, 30, 45, and 60.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02293824, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2017.

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