Dexamethasone Therapy in VLBW Infants at Risk of CLD

NCT00011362 | Completed Phase 3 DMC

• 19 other identifiers: NICHD-NRN-0005U10HD027881U10HD021373U10HD027851U10HD027853U10HD021397U01HD019897U10HD021415U10HD027856U10HD021364U10HD027880U10HD027904U10HD027871U10HD021385M01RR000997M01RR008084M01RR000750M01RR000070M01RR006022
• Study Type: interventional
• Target: 371
• Locations: 1 country
• Sites: 13

Brief Summary

Infants who are on breathing support are often treated with steroids (dexamethasone); however, the best timing of therapy is not known. This trial looked at the benefits and hazards of starting dexamethasone therapy at two weeks of age and four weeks of age in premature infants.

Conditions

Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; Bronchopulmonary Dysplasia

Keywords

NICHD Neonatal Research Network; Extremely Low Birth Weight (ELBW); Prematurity; Dexamethasone; Glucocorticoids; Respiratory Distress Syndrome; Respiratory insufficiency; Steroids

Outcome Measures

Primary Outcomes (1)

• Number of days from randomization to ventilator independence, defined as extubation not requiring reintubation, or extubation followed by elective reintubation for seven days or less so that the infant could undergo a surgical procedure

  At hospital discharge

Secondary Outcomes (6)

• Death before discharge from the hospital

  At hospital discharge

• Duration of assisted ventilation

  At hospital discharge

• Duration of supplemental oxygen therapy

  At hospital discharge

• Duration of hospital stay

  At hospital discharge

• Incidence of chronic lung disease

  At hospital discharge

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

Dexamethasone

Drug: Dexamethasone Early; Drug: Dexamethasone Late

Placebo

PLACEBO COMPARATOR

Saline

Drug: Dexamethasone Early; Drug: Dexamethasone Late

Interventions

Dexamethasone Early DRUG

Tapering course of dexamethasone in doses given twice a day (0.25 mg per kilogram of body weight per dose for five days, then 0.15 mg, 0.07 mg, and 0.03 mg per kilogram per dose for three days each), followed by two weeks of saline.

Dexamethasone; Placebo

Dexamethasone Late DRUG

Saline for two weeks, followed by either the same tapering two-week course of dexamethasone given to the first group, if the respiratory-index score was \>=2.4 on treatment day 14, or an additional two weeks of saline

Dexamethasone; Placebo

Eligibility Criteria

• Age: 13 Days - 15 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to 1500 grams
• to 15 days old
• Respiratory-index score of greater than or equal to 2.4 that had been increasing or minimally decreasing during the previous 48 hours or a score of greater than or equal to 4.0 even if there had been improvement during the preceding 48 hours

You may not qualify if:

• Received glucocorticoid treatment after birth
• Had evidence or suspicious signs of sepsis as judged by the treating physician
• Major congenital anomaly of the cardiovascular, pulmonary, or central nervous system

Sponsors & Collaborators

• NICHD Neonatal Research Network: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (13)

Stanford University

Palo Alto, California, 94304, United States

Location

Yale University

New Haven, Connecticut, 06504, United States

Location

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

University of Tennessee

Memphis, Tennessee, 38163, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

Related Publications (5)

• Papile LA, Tyson JE, Stoll BJ, Wright LL, Donovan EF, Bauer CR, Krause-Steinrauf H, Verter J, Korones SB, Lemons JA, Fanaroff AA, Stevenson DK. A multicenter trial of two dexamethasone regimens in ventilator-dependent premature infants. N Engl J Med. 1998 Apr 16;338(16):1112-8. doi: 10.1056/NEJM199804163381604.

  PMID: 9545359 RESULT

• Leitch CA, Ahlrichs J, Karn C, Denne SC. Energy expenditure and energy intake during dexamethasone therapy for chronic lung disease. Pediatr Res. 1999 Jul;46(1):109-13. doi: 10.1203/00006450-199907000-00018.

  PMID: 10400143 RESULT

• Stoll BJ, Temprosa M, Tyson JE, Papile LA, Wright LL, Bauer CR, Donovan EF, Korones SB, Lemons JA, Fanaroff AA, Stevenson DK, Oh W, Ehrenkranz RA, Shankaran S, Verter J. Dexamethasone therapy increases infection in very low birth weight infants. Pediatrics. 1999 Nov;104(5):e63. doi: 10.1542/peds.104.5.e63.

  PMID: 10545589 RESULT

• Lee BH, Stoll BJ, McDonald SA, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network. Adverse neonatal outcomes associated with antenatal dexamethasone versus antenatal betamethasone. Pediatrics. 2006 May;117(5):1503-10. doi: 10.1542/peds.2005-1749.

  PMID: 16651303 RESULT

• Lee BH, Stoll BJ, McDonald SA, Higgins RD; National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental outcomes of extremely low birth weight infants exposed prenatally to dexamethasone versus betamethasone. Pediatrics. 2008 Feb;121(2):289-96. doi: 10.1542/peds.2007-1103.

  PMID: 18245420 RESULT

Related Links

• Click here for more information on the NICHD Neonatal Research Network.

MeSH Terms

Conditions

Premature Birth; Bronchopulmonary Dysplasia; Respiratory Distress Syndrome; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiration Disorders

Study Officials

• Lu-Ann Papile, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• Jon E. Tyson, MD MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Barbara J. Stoll, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Edward F. Donovan, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Charles R. Bauer, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Sheldon B. Korones, MD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

• James A. Lemons, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

• Avroy A. Fanaroff, MD

  Rainbow Babies & Children's Hospital, Case Western Reserve University

  PRINCIPAL INVESTIGATOR

• David K. Stevenson, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Seetha Shankaran, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• William Oh, MD

  Women & Infants' Hospital, Brown University

  PRINCIPAL INVESTIGATOR

• Richard A. Ehrenkranz, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: February 15, 2001
• First Posted: February 19, 2001
• Study Start: September 1, 1992
• Primary Completion: January 1, 1994
• Study Completion: April 1, 1994
• Last Updated: March 22, 2019

Record last verified: 2019-03

Locations

US (13)