From HGF-Peds: SGA and rGH Resource Message

[Guest guest]

Katy -

This study is very interesting. Our Ped Endo just went back to New York

regarding this same information. We have an appointment with him on December

6 to discuss. He is one of 20 endo's that was invited to New York.

Passaglia

(daughter Jordan 8)

[Guest guest]

Katy -

This study is very interesting. Our Ped Endo just went back to New York

regarding this same information. We have an appointment with him on December

6 to discuss. He is one of 20 endo's that was invited to New York.

Passaglia

(daughter Jordan 8)

[Guest guest]

Hi Everyone---

I know that not all our RSS kids were born IUGR (small at birth, due to

birth growth in utero), but when I saw this very detailed medical

abstract info from the other list serve I belong to (HGF-Peds: Human

Growth Foundation), I thought I would pass on the info. There are

studies dealing with GHT treatment that some may be interested in. Also

good website links, and text FDA approval for GHT use.

Lots of technical stuff, for those of you who are hungry for such info.

I have to admit I have not waded through it yet...

Katy

Earl Gershenow wrote:

I. SGA DEFINED

> " Infants with IUGR are a heterogeneous group with birth weight or

> length, or both below the 10th percentile for gestational age. . . .

> Most appropriate for gestational age, low-birth rate infants

> experience catchup growth during the first 2 y of life, in contrast to

> the slower, attenuated growth of small-for-gestational age infants who

> may have persistent height deficits throughout childhood and

> adolescence. The earlier in gestation that fetal growth is impaired,

> the less likely that complete recapture of lost growth will occur. "

> Textbook of Endocrinology, 9th Ed. (W.B. Saunders,

> Philadelphia: 1998) at p. 1455. " Intra Uterine Growth Retardation

> (IUGR) refers to insufficient fetal growth diagnosed either by two

> direct intrauterine growth assessment (ultra-sonography) or when the

> fetus or newborn length (height) is less than two standard deviations

> (or third percentile) below the mean for gestational age (NIKLASSON

> et. al. 1991; DE ZEGLER 1997). When the fetus or newborn body size

> (weight or length) is insufficient for gestational age, that is less

> than 2 standard deviations below the mean (or third percentile) for

> gestation during the situation is referred to as Small for Gestational

> Age (SGA). Since both fetal weight and length (height) gains are

> closely related, there is much overlap between SGA and IUGR. The

> proportion of newborn with normal birth weight and overlap between SGA

> and IUGR, isolated low birth weight, isolate low birth length and

> combined low birth weight and length is presented in Tab. 1, according

> to the most recent series reported by NIKLASSON (1991). SGA/IUGR is a

> public health problem, since 2.5-3.0 % of newborns are affected by

> definition, and 8-10 % of them do not catch up postnatally, presenting

> with a persistent severe height deficiency, developmental difficulties

> and poor outcome (UNDERWOOD 1991; SIEGEL et al. 1991;

> Albertson-WICKLAND et. al. 1993; LAKEMAN et al. 1994). " " Children

> born with intra-uterine growth retardation (IUGR) or small for

> gestational age (SGA): long term growth and metabolic consequences.

> Chatelain P. Endocr Regul. 2000 Mar;34(1):33-6. Hospital Debrousse,

> Endocrinologie Pediatrique, Universite Claude Bernard & INSERM U369,

> Lyon, France. " See also: Perinatal predictors of growth at six months

> in small for

> gestational age babies. McCowan L, Harding J, Barker S, Ford C. Early

> Hum Dev. 1999 Dec;56(2-3):205-16. Department of Obstetrics and

> Gynaecology, University of Auckland, New Zealand.

> l.mccowan@...; Children born

> small-for-gestational age: postnatal growth and hormonal status.

> Albertsson-Wikland K, Boguszewski M, Karlberg J. Horm Res. 1998;49

> Suppl 2:7-13. International Pediatric Growth Research Center,

> Department of Pediatrics, University of Goteborg, Sweden.

> kerstin.albertsson-wikland@...; A comparison of birth weight

> and weight/length ratio for gestation as correlates of perinatal

> morbidity. MC, O'Brien WF. J Perinatol. 1997

> Sep-Oct;17(5):346-50. Department of Obstetrics and Gynecology,

> University of South Florida, Tampa 33606, USA. II. INFORMATION ON

> SGA ON THE INTERNET FOR THE LAYPERSON (contributed by HGF-PEDS

> member Hodges,

> D.V.M.) SGAhttp://www.drhull.com/EncyMaster/S/SGA.html Gestational

> Agehttp://www.drhull.com/EncyMaster/G/gestational_age.html

IUGRhttp://www.drhull.com/EncyMaster/I/IUGR.html Gestational

> Age Calculatorhttp://health.upenn.edu/fetus/gestage.html About the

> Gestational Age

> Calculatorhttp://health.upenn.edu/fetus/calcinfo.html III. MEDICAL

> LITERATURE A. Abstracts We now have 76 abstracts on SGA and

> growth hormone, current through December 3, 2001. Ask me for the text

> file entitled GHSGA1.TXT. Reading abstracts. Read at least the

> purpose and conclusions of the studies in the abstracts. The

> abstracts, in themselves, do not represent a consensus of medical

> opinion. They are intended to introduce you to issues that you may

> want to discuss with your physician. In addition, we now have

> available on-line full-text reprints that you may request for me.

> Please request only the ones of particular interest to you. The

> reprints are in PDF format, thus appearing in presentation and format

> as they do in the printed publications. B. On-Line Full-Text

> Articles of Studies on SGA and rGH (except where otherwise indicated)

> from the Journal of Clinical Endocrinology and Metabolism (The

> Endocrine Society).1. Francis de Zegher, Kerstin

> Albertsson-Wikland, Hartmut A. Wollmann, Pierre Chatelain, Jean-Louis

> Chaussain, Annika Löfström, Björn Jonsson, and Ron G. Rosenfeld

>

> Growth Hormone Treatment of Short Children Born Small for Gestational

> Age: Growth Responses with Continuous and Discontinuous Regimens Over

> 6 Years

> J. Clin. Endocrinol. Metab. 2000 85: 2816-2821.2. Theo Sas,

> Mulder, and Anita Hokken-Koelega Body Composition, Blood Pressure, and

> Lipid Metabolism before and during Long-Term Growth Hormone (GH)

> Treatment in Children with Short Stature Born Small for Gestational

> Age Either with or without GH Deficiency J. Clin. Endocrinol. Metab.

> 2000 85: 3786-3792. 3. Lourdes Ibáñez, Neus Potau, and Francis de

> ZegherOvarian Hyporesponsiveness to Follicle Stimulating Hormone in

> Adolescent Girls Born Small for Gestational Age

> J. Clin. Endocrinol. Metab. 2000 85: 2624-2626. 4. Francis de

> Zegher, Marc V. L. Du Caju, Claudine Heinrichs, Marc Maes, De

> Schepper, Margareta Craen, Karin Vanweser, Malvaux, and Ron

> G. Rosenfeld Early, Discontinuous, High Dose Growth Hormone Treatment

> to Normalize Height and Weight of Short Children Born Small for

> Gestational Age: Results Over 6 Years

> J. Clin. Endocrinol. Metab. 1999 84: 1558-1561. 5. Theo Sas, Wouter

> de Waal, Mulder, Mieke Houdijk, Maarten Jansen, Maarten Reeser,

> and Anita Hokken-Koelega Growth Hormone Treatment in Children with

> Short Stature Born Small for Gestational Age: 5-Year Results of

> a Randomized, Double-Blind, Dose-Response Trial

> J. Clin. Endocrinol. Metab. 1999 84: 3064-3070. 6. Lourdes Ibáñez,

> Neus Potau, Marcos, and Francis de ZegherExaggerated

> Adrenarche and Hyperinsulinism in Adolescent Girls Born Small for

> Gestational Age

> J. Clin. Endocrinol. Metab. 1999 84: 4739-4741.

> 7. A. L. Ogilvy-Stuart, S. J. Hands, C. J. Adcock, J. M. P. Holly,

> D. R. s, V. Mohamed-Ali, J. S. Yudkin, A. R. Wilkinson,

> and D. B. Dunger Insulin, Insulin-Like Growth Factor I (IGF-I),

> IGF-Binding Protein-1, Growth Hormone, and Feeding in the Newborn

> J. Clin. Endocrinol. Metab. 1998 83: 3550-3557.

>

> 8. ne Leger, Garel, Anne Fjellestad-sen, Max

> Hassan, and Czernichow Human Growth Hormone Treatment of

> Short-Stature Children Born Small for Gestational Age: Effect on

> Muscle andAdipose Tissue Mass during a 3-Year Treatment Period and

> after 1 Year’s Withdrawal

> J. Clin. Endocrinol. Metab. 1998 83: 3512-3516.

>

> 9. Cesar L. Boguszewski, Chatarina Jansson, Margaret C. S.

> Boguszewski, Sten Rosberg, Björn Carlsson, Kerstin Albertsson-Wikland,

> and Lena M. S. Carlsson Increased Proportion of Circulating

> Non-22-Kilodalton Growth Hormone Isoforms in Short Children: A

> Possible Mechanism for Growth Failure

> J. Clin. Endocrinol. Metab. 1997 82: 2944-2949.10. Margaret

> Boguszewski, Ragnar Bjarnason, Sten Rosberg, Lena M. S. Carlsson, and

> Kerstin Albertsson-Wikland

>

> Growth Hormone (GH)-Binding Protein in Prepubertal Short Children Born

> Small for Gestational Age: Effects of Growth Hormone Treatment

> J. Clin. Endocrinol. Metab. 1997 82: 1014-1019.

>

> 11. Akira Harigaya, Kanji Nagashima, Yasushi Nako, and Akihiro

> Morikawa

>

> Relationship between Concentration of Serum Leptin and Fetal Growth

> J. Clin. Endocrinol. Metab. 1997 82: 3281-3284.12. H. A. Koistinen,

> V. A. Koivisto, S. Andersson, S.-L. Karonen, K. Kontula, L. Oksanen,

> and K. A. Teramo Leptin Concentration in Cord Blood Correlates with

> Intrauterine Growth

> J. Clin. Endocrinol. Metab. 1997 82: 3328-3330.

>

> 13. M Boguszewski, C Jansson, S Rosberg, and K

> Albertsson-Wikland Changes in serum insulin-like growth factor I

> (IGF-I) and IGF-binding protein-3 levels during growth hormone

> treatment in prepubertal short children born small for gestational age

>

> J. Clin. Endocrinol. Metab. 1996 81: 3902-3908. [Abstract] 14. M

> Boguszewski, S Rosberg, and K Albertsson-Wikland Spontaneous 24-hour

> growth hormone profiles in prepubertal small for gestational age

> children

> J. Clin. Endocrinol. Metab. 1995 80: 2599-2606. [Abstract]

>

> 15. KS Langford, KH Nicolaides, J , A Abbas, AM McGregor, and

> JP Miell Serum insulin-like growth factor-binding protein-3 (IGFBP-3)

> levels and IGFBP-3 protease activity in normal, abnormal, and multiple

> human pregnancyJ. Clin. Endocrinol. Metab. 1995 80: 21-27.

> [Abstract] 16. A Sasaki, S Yumita, S Kimura, Y Miura, and K

> Yoshinaga Immunoreactive corticotropin-releasing hormone, growth

> hormone- releasing hormone, somatostatin, and peptide histidine

> methionine are present in adrenal pheochromocytomas, but not in

> extra-adrenal pheochromocytoma

> J. Clin. Endocrinol. Metab. 1990 70: 996-999. [Abstract] 17. M

> Deiber, P Chatelain, D Naville, G Putet, and B Salle Functional

> hypersomatotropism in small for gestational age (SGA) newborn infants

> J. Clin. Endocrinol. Metab. 1989 68: 232-234. [Abstract] 18. AM

> Cotterill, CT Cowell, RC Baxter, D McNeil, and M Silinik Regulation of

> the growth hormone-independent growth factor-binding protein in

> children

> J. Clin. Endocrinol. Metab. 1988 67: 882-887. [Abstract]

>

> 19. DJ Hill, M Freemark, AJ Strain, S Handwerger, and RD Milner

> Placental lactogen and growth hormone receptors in human fetal

> tissues: relationship to fetal plasma human placental lactogen

> concentrations and fetal growth

> J. Clin. Endocrinol. Metab. 1988 66: 1283-1290. [Abstract]

>

> 20. PG Bundesen, RG Drake, K , IG Worsley, HG Friesen, and AH

> Sehon

> Radioimmunoassay for human growth hormone using monoclonal antibodies

> J. Clin. Endocrinol. Metab. 1980 51: 1472-1474. [Abstract]

>

> IV. FDA APPROVAL OF USE OF rGH FOR SGA On July, 25, 2001, FDA

> approved the use of Genotropin rGH for use in pediatric patients born

> small for gestational age. (NDA 20-280/S-031). Below is information

> from the draft Full Prescribing Statement (Packing Statement) by

> Pharmacia:

>

> " Pediatric Patients Born Small for Gestational Age (SGA) Who Fail to

> Manifest Catch-up Growth by Age 2 The safety and efficacy of

> GENOTROPIN in the treatment of children born small for gestational age

> (SGA) were evaluated in 4 randomized, open-label, controlled clinical

> trials. Patients (age range of 2 to 8 years) were observed for 12

> months before being randomized to receive either GENOTROPIN (two doses

> per study, most often 0.24 and 0.48 mg/kg/week) as a daily SC

> injection or no treatment for the first 24 months of the studies.

> After 24 " Patients who received any dose of GENOTROPIN showed

> significant increases in growth during the first 24 months of study,

> compared with patients who received no treatment (see Table 4).

> Children receiving 0.48 mg/kg/week demonstrated a significant

> improvement in height standard deviation score (SDS) compared with

> children treated with 0.24 mg/kg/week. Both of these doses resulted in

> a slower but constant increase in growth between months 24 to 72 (data

> not shown). In the studies, all patients received GENOTROPIN. "

>

> " INDICATIONS AND USAGE " " GENOTROPIN Lyophilized Powder is indicated

> for: "

>

> " . Long-term treatment of growth failure in children born small for

> gestational age (SGA) who fail to manifest catch-up growth by age 2. "

>

> You can obtain more information on rGH and rGH and SGA) at

> http://www.fda.gov/cder/. Place the above NDA number given above in

> the search window and " go " (search). The documents are on PDA format;

> and, you will need to download. Earl

>

[Guest guest]

Oops, that should have said, " poor growth " , not " birth growth " ...

Katy Badt-Frissora wrote:

> Hi Everyone---

>

> I know that not all our RSS kids were born IUGR (small at birth, due to

> birth growth in utero),

[Guest guest]

Oops, that should have said, " poor growth " , not " birth growth " ...

Katy Badt-Frissora wrote:

> Hi Everyone---

>

> I know that not all our RSS kids were born IUGR (small at birth, due to

> birth growth in utero),