NCT04044976

Brief Summary

Background. In recent years, particular attention has been paid to all interventions that could help reduce the need for mechanical ventilation MV and, therefore, the risk of BPD. However, early application of non-invasive respiratory supports and early treatment with surfactant fail in 45-50% of cases. Failure frequently depends on the onset of apnea episodes and, therefore, it has been proposed to treat very preterm infants with caffeine already in the delivery room in the first min of life. Hypothesis and objectives of the study. Our aim is to verify the hypothesis that it is possible to administer caffeine in the delivery room intravenously and enterally via an orogastric tube. Study design. Infants 25-29 weeks of gestational age will be enrolled and will be randomized to receive 20 mg/kg of caffeine citrate intravenously, via the umbilical vein, or enterally, through an orogastric tube, within 10 min of birth. The dosage of plasma caffeine concentration will be performed 60+15 min after administration to measure its peak and 60+15 min before the next dose (5 mg/kg/day i.v.). Endpoints. The primary endpoint will be the evaluation of the success rate of intravenous or enteral administration of caffeine in the delivery room. Secondary endpoints will be the evaluation of: number of infants in whom caffeine will be successfully administered by intravenous versus enteral route; number of infants where caffeine will be successfully administered that reached the therapeutic plasmatic range the first dose, confirming the success of the administration; comparison of caffeine blood level obtained with intravenous and enteral administration; frequency of successes in obtaining the therapeutic range after the second dose; frequency of MV within the first 72 hours of life in studied infants. Statistical analysis. In the absence of previous studies to use as a reference and this study being a feasibility study, it was decided arbitrarily to study 20 infants treated in the delivery room with caffeine administered intravenously and 20 infants treated in the delivery room with caffeine administered enterally. The clinical characteristics of the two groups will be described by calculating the mean value and the standard deviation or the rate and percentage. The primary endpoint will be evaluated by calculating the percentage of cases in which caffeine will be successfully administered. The comparison between the number of infants in which caffeine will be successfully administered intravenously versus the enteral route and the comparison between the caffeine plasma level obtained with intravenous and enteral administration will be performed using the Student "t" test for continuous parametric variables, the Wilcoxon rank sum test for non-parametric continuous variables and the χ2 test for categorical variables. A p \<0.05 will be considered as statistically significant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration 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

First Submitted

Initial submission to the registry

July 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

July 30, 2019

Last Update Submit

March 8, 2023

Conditions

Respiratory Distress Syndrome

Keywords

Caffeinedelivery roompreterm infant

Outcome Measures

Primary Outcomes (1)

  • Successful rate

    Evaluation of the number of infants in which the administration of intravenous or enteral caffeine in the delivery room will occur successfully

    10 minutes after birth

Secondary Outcomes (4)

  • Comparison of intravenous versus enteral route

    10 minutes after birth

  • Caffeine administration and its therapeutic range

    90 minutes after birth

  • Intravenous vs enteral caffeine administration and therapeutic range

    90 minutes after birth

  • Need of mechanical ventilation

    72 hours of life

Study Arms (1)

Treated infants

EXPERIMENTAL

Infants who will receive caffeine in the delivery room.

Drug: Caffeine Citrate

Interventions

Caffeine CitrateDRUG

Infants will receive 20 mg/kg of caffeine citrate intravenously, via the umbilical vein, or enterally, through an orogastric tube, within 10 min of birth.

Also known as: Caffeine
Treated infants

Eligibility Criteria

Age1 Minute - 10 Minutes
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Inborn infants
  • Infants with 25+0-29+6 weeks of gestational age
  • Infants who do not require MV in the delivery room

You may not qualify if:

  • Maternal consumption of caffeine before giving birth (\> 2 cups of coffee in the 6 hours before birth)
  • Major congenital malformations
  • Chromosomal syndromes
  • Fetal hydrops
  • Inherited metabolic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Neonatology, Careggi University Hospital

Florence, 50134, Italy

Location

Related Publications (2)

  • Dani C, Cecchi A, Ciarcia M, Miselli F, Luzzati M, Remaschi G, Bona MD, la Marca G, Boni L. Enteral and Parenteral Treatment with Caffeine for Preterm Infants in the Delivery Room: A Randomised Trial. Paediatr Drugs. 2023 Jan;25(1):79-86. doi: 10.1007/s40272-022-00541-y. Epub 2022 Oct 27.

    PMID: 36301511DERIVED

  • Dani C, Cecchi A, Remaschi G, Mercadante D, la Marca G, Boni L, Mosca F. Study protocol: treatment with caffeine of the very preterm infant in the delivery room: a feasibility study. BMJ Open. 2020 Dec 4;10(12):e040105. doi: 10.1136/bmjopen-2020-040105.

    PMID: 33277284DERIVED

MeSH Terms

Conditions

Respiratory Distress SyndromePremature Birth

Interventions

caffeine citrateCaffeine

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: A cohort of preterm infants will be given caffeine in the delivery room
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Pediatrics

Study Record Dates

First Submitted

July 30, 2019

First Posted

August 5, 2019

Study Start

August 1, 2019

Primary Completion

June 30, 2021

Study Completion

August 31, 2021

Last Updated

March 10, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

Data will be collected in electronic sheet. These data will be available on request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data will become available at the end of the study.
Access Criteria
Access will be allowed on request.

Locations

IT(1)