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Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial

Information source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pregnancy; Respiratory Distress; Pregnancy Outcome

Intervention: Corticosteroid (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Official(s) and/or principal investigator(s):
Uma Reddy, MD, MPH, Study Director, Affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Elizabeth Thom, PhD, Principal Investigator, Affiliation: George Washington University
Cynthia Gyamfi Bannerman, MD, Study Chair, Affiliation: Columbia University

Overall contact:
Uma Reddy, MD, MPH, Phone: 301-496-1074, Email: uma.reddy@nih.gov


Infants born between 34 and 36 weeks of gestation, known as 'late preterm', are more likely to be admitted to a special care nursery, and more likely to suffer respiratory complications than infants born at term. The use of antenatal corticosteroids has been shown to improve lung function in very premature infants, but has not been evaluated in those likely to deliver in the late preterm period. This research study will attempt to answer the following primary research question: Do steroids, compared to no steroids, decrease babies' need for oxygen support when given to pregnant women at least 12 to 24 hours before they deliver at 34 weeks to 36 weeks gestation? The research study will also collect information on whether steroids improve the chances that the baby will not get sick from other causes.

Clinical Details

Official title: Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: Composite Outcome

Secondary outcome:

Maternal outcomes

Neonatal morbidity / mortality

Respiratory Distress Syndrome

Neonatal composite

Need for immediate resuscitation after birth

Surfactant use

Chronic lung disease (BPD)

Necrotizing enterocolitis (NEC)

Morbidity composite

Birth weight



Feeding difficulty


Neonatal infectious morbidity

Seizures / encephalopathy

Length of hospital stay

Number of and reason for infant re-hospitalizations, ER visits or unanticipated visits to the primary care pediatrician / specialist

Detailed description: Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial: The rate of preterm birth has steadily increased in the United States over the past 10 years. This increase is driven in part by the rising rate of late preterm birth, defined as those births occurring between 34 and 36 weeks. Late preterm infants experience a higher rate of readmission than their term counterparts, and these infants are more likely to suffer complications such as respiratory distress, kernicterus, feeding difficulties, and hypoglycemia. Late preterm infants also have a higher mortality for all causes when compared to term infants. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period. If shown to reduce the need for respiratory support and thus to decrease the rate of special care nursery admissions and improve short-term outcomes, the public health and economic impact will be considerate. This protocol describes a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of neonatal intensive care unit (NICU) admissions and improving short-term outcomes in the late preterm infant.


Minimum age: N/A. Maximum age: N/A. Gender(s): Female.


Inclusion Criteria: Singleton Pregnancy. A twin pregnancy reduced to singleton (either spontaneously or therapeutically) before 14,0 weeks by project gestational age is acceptable Gestational age at randomization between 34,0weeks and 36,5 weeks confirmed by study criteria High probability of delivery in the late preterm period (any one of the following):

- Membrane rupture as defined by the study criteria.


- Preterm labor with intact membranes. Preterm labor is defined as at least 6 regular

uterine contractions in an observation period of no more than 60 minutes and at least one of the following: cervix greater than or equal to 3cm dilated or 80% effaced or

- Planned delivery by induction of labor or cesarean section in no less than 24 hours

and no more than 7 days, as deemed necessary by the provider. An induction must be scheduled to start by 36,5 weeks at the latest, whereas a cesarean delivery must be scheduled by 36,6 weeks at the latest. Therefore the latest gestational age for randomization is 36,4 weeks for a planned induction. The planned delivery may be for any indication, such as the following: prior myomectomy, prior classical cesarean, intrauterine growth restriction (IUGR), oligohydramnios, preeclampsia, nonreassuring fetal heart rate tracing warranting delivery, abruption, placenta previa Exclusion Criteria:

- Rupture of Membranes (ROM) does not satisfy protocol criteria - exclude if the

patient being evaluated for Preterm Premature Rupture of Membranes (pPROM) does not have preterm labor or planned delivery and does not satisfy the spontaneous membrane rupture criteria (any 2 of: positive Nitrazine test, pooling of fluid in the vaginal vault test or ferning of vaginal fluid; or indigo carmine pooling in the vagina after amnioinfusion; or visible leakage of amniotic fluid from the cervix)

- Preterm labor does not satisfy protocol criteria - exclude if patient has intact

membranes with no delivery planned and contractions are more than 10 minutes apart or if the cervix is both less than 3cm dilated and less than 80% effaced

- Fetal death / major fetal anomaly / fetus non-viable - exclude if the patient has a

major fetal anomaly or the fetus is not viable

- Delivery expected < 12 hours after randomization - this includes 1) ruptured

membranes with cervical dilation ≥ 3cm or more than 6 contractions per hour unless pitocin is deferred for at least 12 hours 2) evidence of non-reassuring fetal status requiring immediate delivery 3) chorio-amnionitis 4) Cervical dilation ≥ 8 cm

- Prior corticosteroids for fetal lung maturity - exclude if patient was given

corticosteroids for fetal lung maturity before 34 weeks

- Systemic corticosteroids for other indications - exclude if patient was given

systemic corticosteroids for indication other than fetal lung maturity

- No ultrasound < 20 weeks for unsure last menstrual period (LMP). If the patient has

an unsure LMP but she had no dating ultrasound before 20 weeks by ultrasound parameters, she is excluded.

- No ultrasound < 24 weeks for sure LMP. If the patient has an sure LMP but she had no

dating ultrasound before 24 weeks by ultrasound parameters, she is excluded

- Cervical dilation ≥ 8 cm

- Project gestational age < 34,0 weeks or ≥ 36,6 weeks

- Delivery planned at project gestational age ≥ 36,6 weeks

- Known congenital malformation

- Fetal reduction/loss ≥ 14 weeks - exclude if the singleton pregnancy is due to

reduction or fetal loss from a twin pregnancy at greater or equal to 14 weeks

- Gestational diabetes

- Pre-gestational diabetes - exclude if the patient was on medication (insulin,

glyburide) prior to pregnancy

- Maternal contraindication to betamethasone - exclude if the patient has a known

contraindication to betamethasone

- Chorioamnionitis - exclude if patient is diagnosed with chorioamnionitis

- Physician planning to give steroids - exclude if patient's physician is planning to

give her steroids

- Physician refusal for other reasons - exclude if patient's physician refuses to allow

the patient to participate in the study

- Refusal to sign medical record release

- Participation in conflicting study / this study before - exclude if the patient is

participating in an antenatal study in which the clinical status or intervention may influence neonatal respiratory outcome, or if she was previously enrolled in this study

- Multifetal gestation. Exclude if current multifetal gestation or a single gestation

resulting from a reduction of a multiple of higher order than twins

- Delivery at a non-participating hospital

- Gestational age 36,0 or more and quota already reached.

Locations and Contacts

Uma Reddy, MD, MPH, Phone: 301-496-1074, Email: uma.reddy@nih.gov

University of Alabama - Birmingham, Birmingham, Alabama 35233, United States; Recruiting
Stacy Harris, RN MSN, Phone: 205-934-1322, Email: stacylharris@uab.edu
Alan T Tita, MD, Principal Investigator

Stanford University, Stanford, California 94305, United States; Recruiting
Cynthia Willson, RN BSN, Phone: 650-724-6372, Email: cwillson@stanford.edu
Yasser El-Sayed, MD, Principal Investigator

University of Colorado, Denver, Colorado 80045, United States; Recruiting
Kathy Hale, RN BSN, Phone: 303-724-6685, Email: kathy.a.hale@ucdenver.edu
Ronald Gibbs, MD, Principal Investigator

Northwestern University, Chicago, Illinois 60611, United States; Active, not recruiting

Wayne State University, Detroit, Michigan 48201, United States; Active, not recruiting

Columbia University, New York, New York 10032, United States; Recruiting
Sabine Bousleiman, Phone: 212-305-4348, Email: sb1080@columbia.edu
Ronald Wapner, MD, Principal Investigator

University of North Carolina - Chapel Hill, Chapel Hill, North Carolina 27599, United States; Active, not recruiting

Duke University, Durham, North Carolina 27710, United States; Recruiting
Tammy Sinclair Bishop, RN, Phone: 919-668-7475, Email: sincl008@mc.duke.edu
Geeta Swamy, MD, Principal Investigator

Case Western Reserve University, Cleveland, Ohio 44109, United States; Recruiting
Wendy Dalton, RNC, Phone: 216-778-7533, Email: wdalton@metrohealth.org
Edward Chien, MD, Principal Investigator

Ohio State University, Columbus, Ohio 43210, United States; Recruiting
Francee Johnson, RN, Phone: 614-293-5632, Email: johnson.126@osu.edu
Jay Iams, MD, Principal Investigator

Oregon Health & Science University, Portland, Oregon 97239, United States; Active, not recruiting

University of Pittsburgh Magee Womens Hospital, Pittsburgh, Pennsylvania 15213, United States; Active, not recruiting

Brown University, Providence, Rhode Island 02905, United States; Recruiting
Donna Allard, RNC, Phone: 401-274-1122, Ext: 8522, Email: dallard@wihri.org
Dwight Rouse, MD, Principal Investigator

University of Texas - Southwest, Dallas, Texas 75235, United States; Active, not recruiting

University of Texas - Galveston, Galveston, Texas 77555, United States; Recruiting
Ashley Salazar, RN MSN WHNP, Phone: 409-772-0312, Email: assalaza@utmb.edu
George Saade, MD, Principal Investigator

University of Texas - Houston, Houston, Texas 77030, United States; Recruiting
Felecia Ortiz, RN, Phone: 713-500-6467, Email: Felecia.Ortiz@uth.tmc.edu
Baha Sibai, MD, Principal Investigator

University of Utah Medical Center, Salt Lake City, Utah 84132, United States; Recruiting
Kim Hill, RN BSN, Phone: 801-585-7645, Email: Kim.Hill@hsc.utah.edu
Michael W Varner, MD, Principal Investigator

Additional Information

(The public website of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal Fetal Medicine Units (MFMU) Network)

Related publications:

Davidoff MJ, Dias T, Damus K, Russell R, Bettegowda VR, Dolan S, Schwarz RH, Green NS, Petrini J. Changes in the gestational age distribution among U.S. singleton births: impact on rates of late preterm birth, 1992 to 2002. Semin Perinatol. 2006 Feb;30(1):8-15. Erratum in: Semin Perinatol. 2006 Oct;30(5):313.

Raju TN, Higgins RD, Stark AR, Leveno KJ. Optimizing care and outcome for late-preterm (near-term) infants: a summary of the workshop sponsored by the National Institute of Child Health and Human Development. Pediatrics. 2006 Sep;118(3):1207-14.

Escobar GJ, Clark RH, Greene JD. Short-term outcomes of infants born at 35 and 36 weeks gestation: we need to ask more questions. Semin Perinatol. 2006 Feb;30(1):28-33. Review.

Hamilton BE, Ventura SJ, Martin JA, and Sutton PD. Preliminary births for 2004. Health E-stats. Hyattsville, MD: National Center for Health Statistics. Released October 28, 2005.

Buus-Frank ME. The great imposter. Adv Neonatal Care. 2005 Oct;5(5):233-6.

Hoyert DL, Mathews TJ, Menacker F, Strobino DM, Guyer B. Annual summary of vital statistics: 2004. Pediatrics. 2006 Jan;117(1):168-83. Erratum in: Pediatrics. 2006 Jun;117(6):2338.

Dudell GG, Jain L. Hypoxic respiratory failure in the late preterm infant. Clin Perinatol. 2006 Dec;33(4):803-30; abstract viii-ix. Review.

Laptook A, Jackson GL. Cold stress and hypoglycemia in the late preterm ("near-term") infant: impact on nursery of admission. Semin Perinatol. 2006 Feb;30(1):24-7.

Neu J. Gastrointestinal maturation and feeding. Semin Perinatol. 2006 Apr;30(2):77-80. Review.

Bhutani VK, Johnson L. Kernicterus in late preterm infants cared for as term healthy infants. Semin Perinatol. 2006 Apr;30(2):89-97.

Moster D, Lie RT, Markestad T. Long-term medical and social consequences of preterm birth. N Engl J Med. 2008 Jul 17;359(3):262-73. doi: 10.1056/NEJMoa0706475.

McIntire DD, Leveno KJ. Neonatal mortality and morbidity rates in late preterm births compared with births at term. Obstet Gynecol. 2008 Jan;111(1):35-41. doi: 10.1097/01.AOG.0000297311.33046.73.

Kramer MS, Demissie K, Yang H, Platt RW, Sauvé R, Liston R. The contribution of mild and moderate preterm birth to infant mortality. Fetal and Infant Health Study Group of the Canadian Perinatal Surveillance System. JAMA. 2000 Aug 16;284(7):843-9.

Gray RF, Indurkhya A, McCormick MC. Prevalence, stability, and predictors of clinically significant behavior problems in low birth weight children at 3, 5, and 8 years of age. Pediatrics. 2004 Sep;114(3):736-43.

Linnet KM, Wisborg K, Agerbo E, Secher NJ, Thomsen PH, Henriksen TB. Gestational age, birth weight, and the risk of hyperkinetic disorder. Arch Dis Child. 2006 Aug;91(8):655-60. Epub 2006 Jun 5.

Clark RH. The epidemiology of respiratory failure in neonates born at an estimated gestational age of 34 weeks or more. J Perinatol. 2005 Apr;25(4):251-7.

Stutchfield P, Whitaker R, Russell I; Antenatal Steroids for Term Elective Caesarean Section (ASTECS) Research Team. Antenatal betamethasone and incidence of neonatal respiratory distress after elective caesarean section: pragmatic randomised trial. BMJ. 2005 Sep 24;331(7518):662. Epub 2005 Aug 22.

Rubaltelli FF, Dani C, Reali MF, Bertini G, Wiechmann L, Tangucci M, Spagnolo A. Acute neonatal respiratory distress in Italy: a one-year prospective study. Italian Group of Neonatal Pneumology. Acta Paediatr. 1998 Dec;87(12):1261-8.

Yoder BA, Gordon MC, Barth WH Jr. Late-preterm birth: does the changing obstetric paradigm alter the epidemiology of respiratory complications? Obstet Gynecol. 2008 Apr;111(4):814-22. doi: 10.1097/AOG.0b013e31816499f4.

Tita AT, Landon MB, Spong CY, Lai Y, Leveno KJ, Varner MW, Moawad AH, Caritis SN, Meis PJ, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai BM, Langer O, Thorp JM, Ramin SM, Mercer BM; Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units Network. Timing of elective repeat cesarean delivery at term and neonatal outcomes. N Engl J Med. 2009 Jan 8;360(2):111-20. doi: 10.1056/NEJMoa0803267.

Wang ML, Dorer DJ, Fleming MP, Catlin EA. Clinical outcomes of near-term infants. Pediatrics. 2004 Aug;114(2):372-6.

Shapiro-Mendoza CK, Tomashek KM, Kotelchuck M, Barfield W, Weiss J, Evans S. Risk factors for neonatal morbidity and mortality among "healthy," late preterm newborns. Semin Perinatol. 2006 Apr;30(2):54-60.

Tomashek KM, Shapiro-Mendoza CK, Weiss J, Kotelchuck M, Barfield W, Evans S, Naninni A, Declercq E. Early discharge among late preterm and term newborns and risk of neonatal morbidity. Semin Perinatol. 2006 Apr;30(2):61-8.

Starting date: October 2010
Last updated: October 28, 2014

Page last updated: August 23, 2015

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