NCT02677584

Brief Summary

Investigators hypothesized that the timing of caffeine administration in either prophylaxis or treatment of apnea of prematurity will affect the apnea response to caffeine

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

3.7 years

First QC Date

January 3, 2016

Last Update Submit

March 12, 2021

Conditions

Apnea

Keywords

caffeineapneapreterm infant

Outcome Measures

Primary Outcomes (1)

  • Duration of Respiratory Support

    60 days from NICU admission

Secondary Outcomes (5)

  • Days of apnea free

    60 days from NICU admission

  • length of hospital stay

    60 days from NICU admission

  • Head ultrasound results

    14 days from NICU admission

  • Necrotizing Enterocolitis

    30 days from NICU admission

  • Retinopathy of prematurity

    60 days from NICU admission

Study Arms (2)

Prophylactic caffeine citrate

ACTIVE COMPARATOR

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

Therapeutic caffeine citrate

ACTIVE COMPARATOR

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

Interventions

Prophylactic caffeine citrateDRUG

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) .

Prophylactic caffeine citrate
Therapeutic caffeine citrateDRUG

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).

Therapeutic caffeine citrate

Eligibility Criteria

Age1 Hour - 12 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Children Hospital

Al Mansurah, El Dakahlya, 35111, Egypt

Location

Related Publications (2)

  • Dobson NR, Patel RM, Smith PB, Kuehn DR, Clark J, Vyas-Read S, Herring A, Laughon MM, Carlton D, Hunt CE. Trends in caffeine use and association between clinical outcomes and timing of therapy in very low birth weight infants. J Pediatr. 2014 May;164(5):992-998.e3. doi: 10.1016/j.jpeds.2013.12.025. Epub 2014 Jan 23.

    PMID: 24461786BACKGROUND

  • Katheria AC, Sauberan JB, Akotia D, Rich W, Durham J, Finer NN. A Pilot Randomized Controlled Trial of Early versus Routine Caffeine in Extremely Premature Infants. Am J Perinatol. 2015 Jul;32(9):879-86. doi: 10.1055/s-0034-1543981. Epub 2015 Jan 21.

    PMID: 25607226BACKGROUND

MeSH Terms

Conditions

ApneaPremature Birth

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Invistigator

Study Record Dates

First Submitted

January 3, 2016

First Posted

February 9, 2016

Study Start

March 1, 2015

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

March 16, 2021

Record last verified: 2021-03

Locations

EG(1)