Early Blood Pressure Management in Extremely Premature Infants (ELGAN BP)

N

NICHD Neonatal Research Network

Status and phase

Completed
Phase 1

Conditions

Hypotension
Infant, Low Birth Weight
Infant, Newborn
Infant, Small for Gestational Age
Infant, Premature
Blood Pressure

Treatments

Drug: Dopamine
Drug: Syringe Placebo
Drug: Infusion Placebo
Drug: Hydrocortisone

Study type

Interventional

Funder types

NETWORK
NIH

Identifiers

NCT00874393
U10HD053109 (U.S. NIH Grant/Contract)
UL1RR024979 (U.S. NIH Grant/Contract)
U10HD021364 (U.S. NIH Grant/Contract)
UL1RR025764 (U.S. NIH Grant/Contract)
U10HD027880 (U.S. NIH Grant/Contract)
U10HD027856 (U.S. NIH Grant/Contract)
U10HD036790 (U.S. NIH Grant/Contract)
U10HD053089 (U.S. NIH Grant/Contract)
U10HD027851 (U.S. NIH Grant/Contract)
U10HD040689 (U.S. NIH Grant/Contract)
UL1RR025747 (U.S. NIH Grant/Contract)
UL1RR025008 (U.S. NIH Grant/Contract)
U10HD027871 (U.S. NIH Grant/Contract)
UL1RR024139 (U.S. NIH Grant/Contract)
U10HD021373 (U.S. NIH Grant/Contract)
U10HD027853 (U.S. NIH Grant/Contract)
NICHD-NRN-0041
U10HD053119 (U.S. NIH Grant/Contract)
UL1RR025744 (U.S. NIH Grant/Contract)
U10HD040492 (U.S. NIH Grant/Contract)
UL1RR025777 (U.S. NIH Grant/Contract)
U10HD053124 (U.S. NIH Grant/Contract)
U10HD034216 (U.S. NIH Grant/Contract)
U10HD021385 (U.S. NIH Grant/Contract)
U10HD027904 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This trial tests the feasibility of enrolling 60 extremely preterm infants in a randomized, double-blinded study of blood pressure management within 12 months. Eligible infants will receive an infusion drug (dopamine or a dextrose placebo) and a syringe drug (hydrocortisone or a normal saline placebo). Enrolled infants will be randomized to receive one of the following drug pairs: * dopamine and hydrocortisone * dopamine and normal saline * dextrose and hydrocortisone * dextrose and normal saline. In addition to the intervention above, the NRN is conducting a 6-month time-limited prospective observational study of all infants born at an NRN center between 23 and 26 weeks gestational age. All clinical decisions made for these babies will be at the discretion of the attending neonatologist/infant care team according to standard practice at each institution. Data on blood pressure management in the first 24 postnatal hours collected for each infant.

Full description

Since most extremely preterm infants are critically ill in the immediate postnatal period, establishing "normal" blood pressure (BP) values is difficult. This lack of data makes deciding when to institute therapy for hypotension (low BP) challenging, leading to considerable variability in BP management in neonatal intensive care units (NICUs). Despite a lack of data on safety or efficacy, as many as 64% of extremely preterm infants receive inotropes (e.g., dopamine), and up to 12.4% of very low birthweight infants receive hydrocortisone for perceived hypotension. Since both untreated low BP and therapy provided for low BP may be harmful, the decision of whether to treat is an important issue. To date, no prospective randomized, controlled trial of BP management in this population has been performed. This trial tests the feasibility of enrolling up to 60 extremely preterm infants in a randomized, double-blinded study of blood pressure management within 12 months. It will enroll 60 infants between 23 0/7 and 26 6/7 weeks gestational age born at 6 participating NICHD Neonatal Research Network sites. Eligible infants will receive a study infusion drug (dopamine or a dextrose placebo) and a study syringe drug (hydrocortisone or a normal saline placebo). Infants will be randomized to receive one of the following drug pairs: (1) dopamine and hydrocortisone; (2) dopamine and a placebo (normal saline solution); (3) a placebo (dextrose) and hydrocortisone; or (4) placebo (dextrose) and placebo (normal saline). (NOTE: dopamine is normally mixed with dextrose and hydrocortisone is mixed with saline solution before being administered, which is why two different placebos are being used in this trial.) The information gathered will provide a framework for the design of a potential larger, multi-centered, randomized control trial. NOTE: The NICHD Neonatal Research Network has received a FDA exemption from the IND regulations for this trial. In addition to the interventional trial above, the NRN is conducting a 6-month time-limited prospective observational study of all infants born at an NRN center between 23 and 26 weeks gestational age. All clinical decisions made for these babies will be at the discretion of the attending neonatologist/infant care team according to standard practice at each institution. Data on blood pressure management in the first 24 postnatal hours collected for each infant. Based on slow rate of recruitment, a time-limited observational study of hypotension in ELBW infants has been added to the current study.

Enrollment

10 patients

Sex

All

Ages

Under 24 hours old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Inborn infants
  • 23 0/7 to 26 6/7 weeks estimated gestational age
  • Umbilical arterial catheter in place at study entry
  • <= 24 hours of age

Exclusion criteria

  • Terminally ill infants
  • Infants that have received (prior to enrollment): >20 ml/kg in fluid boluses, indomethacin, or ibuprofen
  • Infants with major congenital anomalies

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

10 participants in 4 patient groups, including a placebo group

Dopamine and hydrocortisone
Active Comparator group
Description:
Dopamine AND hydrocortisone
Treatment:
Drug: Hydrocortisone
Drug: Dopamine
Dopamine and placebo
Active Comparator group
Description:
Dopamine AND normal saline placebo
Treatment:
Drug: Syringe Placebo
Drug: Dopamine
Placebo and hydrocortisone
Active Comparator group
Description:
Dextrose (D5W) placebo AND hydrocortisone
Treatment:
Drug: Hydrocortisone
Drug: Infusion Placebo
Placebo and Placebo
Placebo Comparator group
Description:
Dextrose (D5W) placebo AND normal saline placebo
Treatment:
Drug: Infusion Placebo
Drug: Syringe Placebo

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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