Fetal growth

Details Fetal growth Fetal growth

1997-06-10

1999-01-12

Tsang, Cecilia J.

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Peptide containing doai

514 3, A61K 3828

Patent

active

058589660

DESCRIPTION:

BRIEF SUMMARY
FIELD OF THE INVENTION

This invention relates to the treatment of mammalian fetuses (including human fetuses) with compositions that enhance the ability of the fetus and neonatal infant to survive.


BACKGROUND

Intrauterine growth retardation (IUGR) remains a major cause of intrauterine and neonatal death and is associated with a high morbidity in the neonatal period and potentially with morbidity extending to adult life. It is frequently associated with abnormalities of placental growth and/or function. IUGR can be diagnosed with standard obstetrical techniques such as ultrasonography. However treatment of IUGR remains inadequate and restricted to either maternal bedrest or premature elective caesarean section.
Immaturity of lung growth and development in fetal life may occur associated with IUGR or independent of it. Isolated failure of fetal lung growth is known as pulmonary hypoplasia and is a significant cause of neonatal death. It may be diagnosed prenatally. In prematurely born infants, immaturity of lung structure and function leads to the respiratory distress syndrome (RDS). RDS is currently treated by ventilation and pulmonary insufflation of surfactant but remains a major problem in neonatal nurseries. It has been the practice for many years to treat women at risk of premature birth or in premature labour, where delivery is delayed pharmaceutically, with steroid hormones which cross the placenta and mature the lungs. However this therapy only partially alleviates RDS.
It is known to those versed in the art that fetal growth is regulated in part by a hormone termed insulin-like growth factor-1 (IGF-1) which circulates in the fetal circulation and which has been demonstrated in a variety of animal models to regulate fetal growth and confirming clinical data are available. IGF-1 is made by fetal tissues. It however does not cross the placenta from mother to fetus. Therefore maternal administration does not directly affect fetal circulating levels of IGF-1 and that maternal administration of IGF-1 affects fetal growth indirectly (Liu L, Harding J E, Evans P C, Gluckman P D. "Maternal IGF-1 alters feto-placental carbohydrate and protein metabolism in pregnant sheep". Endocrinology 135 895-900; 1994). IGF-1 in the fetal circulation is derived from fetal tissues in particular from the fetal liver.
It is also known that the fetus swallows amniotic fluid.


OBJECT

It is an object of the present invention to provide an improved composition and/or method for treating intrauterine growth retardation or one which will at least provide the public with a useful choice.


STATEMENT OF THE INVENTION

In a first broad aspect the invention provides method of enhancing growth and/or maturation of a fetus and/or its immune system and/or its organs characterised in that IGF-1 is administered to amniotic fluid or to the gastrointestinal tract of the fetus.
Preferably the IGF-1 is administered to the amniotic fluid to promote placental growth.
More preferably the IGF-1 is administered to the amniotic fluid by a single or repeated amniocentesis injection.
Alternatively the IGF-1 is administered to the amniotic fluid by placement of a chronic cannula.
Alternatively the IGF-1 is administered into the fetal gastrointestinal tract by injection or placement of a catheter.
Preferably IGF-1 is chosen from the group comprising recombinant human IGF-1, or the recombinant form of its naturally occurring analogue des 1-3N IGF-1.
Preferably the IGF-1 is administered together with recombinant forms of its binding protein.
Preferably the dose of IGF-1 administered per day is in the range of 1-100 .mu.g/kg estimated fetal weight.
In another aspect the invention provides a composition for enhancing fetal growth comprising an effective amount of IGF-1 and a pharmaceutically acceptable carrier.
In another aspect the invention is concerned with the use of IGF-1 in the manufacture of a composition to enhance fetal growth.
The IGF-1 can be administered into amniotic fluid surrounding the fetus or to the gastrointestinal tract of the fetu

REFERENCES:
patent: 5420111 (1995-05-01), Gluckman et al.
Harding et al., Eudocrinology, vol. 134, No. 3, pp. 1509-1514.
Liu et al., Endocrinology, vol. 124, No. 6, pp. 3077-3082.

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