Growth Observational Study (Growth)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01203475 |
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Recruitment Status :
Completed
First Posted : September 16, 2010
Last Update Posted : June 8, 2015
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| Condition or disease |
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| Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature |
Previous growth curves for premature infants were based on a 1948 study of 100 infants. More recent reports described growth rates for VLBW infants exceeded those predicted by the previous study. The authors suggested that the differences may reflect changes in nutritional management and cautioned that the observed growth rates may not be optimal. Although a greater number of extremely low birth weight infants were included in these studies, data for infants with birth weights <750 g was still limited.
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.
Data were collected on 1660 infants with birth weights between 501 to 1500 g who were inborn or admitted at 24 hours of age or less to 1 of the 12 National Institute of Child Health and Human Development (NICHD) Neonatal Research Network centers between August 31, 1994 and August 9, 1995, survived >7 days (168 hours) and were free of major congenital anomalies. Infants were weighed daily for a minimum of 14 days or until birth weight was regained, whichever occurred later, and then weekly. Recumbent length was measured weekly with a Premie Length Board. Head circumference (HC) was measured weekly. Midarm circumference (MAC) was measured weekly. Length, HC, and MAC measurements were each performed twice.
| Study Type : | Observational |
| Actual Enrollment : | 1660 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Growth Observational Study |
| Study Start Date : | August 1994 |
| Actual Primary Completion Date : | August 1995 |
| Actual Study Completion Date : | August 1995 |
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| Ages Eligible for Study: | up to 24 Hours (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Major congenital anomalies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203475
| United States, California | |
| Stanford University | |
| Palo Alto, California, United States, 94304 | |
| United States, Connecticut | |
| Yale University | |
| New Haven, Connecticut, United States, 06504 | |
| United States, District of Columbia | |
| George Washington University | |
| Washington, District of Columbia, United States, 20052 | |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30303 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, Ohio | |
| Cincinnati Children's Medical Center | |
| Cincinnati, Ohio, United States, 45267 | |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Rhode Island | |
| Brown University, Women & Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| United States, Tennessee | |
| University of Tennessee | |
| Memphis, Tennessee, United States, 38163 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75235 | |
| Study Director: | Richard A. Ehrenkranz, MD | Yale University | |
| Principal Investigator: | 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 |
Publications of Results:
Other Publications:
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NICHD Neonatal Research Network Extremely Low Birth Weight (ELBW) Prematurity |
Growth Curve Head Circumference Length |
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Birth Weight Body Weight |