Growth Observational Study

NCT01203475 | Completed

• 19 other identifiers: NICHD-NRN-0013U10HD021364U10HD027853M01RR008084U10HD027851U01HD019897U10HD027856M01RR000750U10HD021397U10HD027881M01RR000997U10HD027880M01RR000070U10HD021415U10HD021373U10HD021385U10HD027904U10HD027871M01RR006022
• Study Type: observational
• Target: 1,660
• Locations: 1 country
• Sites: 13

Brief Summary

This study was a multicenter, prospective cohort study to define postnatal longitudinal growth for very low birth weight (VLBW) infants. The objectives were: 1) to develop postnatal growth curves for VLBW preterm infants that would permit an assessment of growth velocity; 2) to relate growth velocity and nutritional practices (duration of parenteral nutrition, age at first enteral feeding, and age at full enteral feeding); 3) to compare growth velocity in infants who are small-for-gestational age (SGA) with infants who are appropriate-for-gestational age (AGA); and 4) to relate growth velocity to several common, major morbidities, including chronic lung disease (CLD), nosocomial infection (or late-onset infection) and necrotizing enterocolitis (NEC). These growth data may be useful in identifying preterm infants who are growing slowly despite current nutritional support and in designing and performing clinical trials of nutritional interventions.

Conditions

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

Keywords

NICHD Neonatal Research Network; Extremely Low Birth Weight (ELBW); Prematurity; Growth Curve; Head Circumference; Length

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Premature infants born at NICHD Neonatal Research Network centers during the study period.

You may qualify if:

• Infants with birth weights between 501 to 1500g who were inborn or admitted at 24 hours of age or less
• Survived \>7 days (168 hours)

You may not qualify if:

• Major congenital anomalies

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 (3)

• Dusick AM, Poindexter BB, Ehrenkranz RA, Lemons JA. Growth failure in the preterm infant: can we catch up? Semin Perinatol. 2003 Aug;27(4):302-10. doi: 10.1016/s0146-0005(03)00044-2.

  PMID: 14510321 BACKGROUND

• Ehrenkranz RA, Younes N, Lemons JA, Fanaroff AA, Donovan EF, Wright LL, Katsikiotis V, Tyson JE, Oh W, Shankaran S, Bauer CR, Korones SB, Stoll BJ, Stevenson DK, Papile LA. Longitudinal growth of hospitalized very low birth weight infants. Pediatrics. 1999 Aug;104(2 Pt 1):280-9. doi: 10.1542/peds.104.2.280.

  PMID: 10429008 RESULT

• Ehrenkranz RA, Dusick AM, Vohr BR, Wright LL, Wrage LA, Poole WK. Growth in the neonatal intensive care unit influences neurodevelopmental and growth outcomes of extremely low birth weight infants. Pediatrics. 2006 Apr;117(4):1253-61. doi: 10.1542/peds.2005-1368.

  PMID: 16585322 RESULT

Related Links

• NICHD Neonatal Research Network

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Richard A. Ehrenkranz, MD

  Yale University

  STUDY DIRECTOR

• Avroy A. Fanaroff, MD

  Case Wester Reserve University

  PRINCIPAL INVESTIGATOR

• Edward F. Donovan, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Barbara J. Stoll, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Joel Verter, PhD

  George Washington University

  PRINCIPAL INVESTIGATOR

• James A. Lemons, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Charles R. Bauer, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Lu-Ann Papile, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• David K. Stevenson, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Sheldon B. Korones, MD

  University of Tennessee at Memphis

  PRINCIPAL INVESTIGATOR

• Jon E. Tyson, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

• Seetha Shankaran, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• William Oh, MD

  Brown University, Womens and Infants Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 16, 2010
• Study Start: August 1, 1994
• Primary Completion: August 1, 1995
• Study Completion: August 1, 1995
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

US (13)