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21.09.2005:
   21.09.2005

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TESTING OF THE AMINO ACID COMPOUND PROVIT IN PREMATURE CHILDREN WITH PERINATAL ENCEPHALOPATHY.

G.V. Yatsyk, Professor, pediatrician;
K.A. Semyonova, M.D., Professor, Honored Scientist of R.S.F.S.R.;
Ye.Ye. Zhitkova, neuropathologist
(published as a progress report)
1997

At present, in connection with a reduced birth rate in Russia and an increase in premature labor, rearing of children, especially those with perinatal central nervous system (CNS) impairment, is becoming an increasingly urgent problem.

This causes physicians to look for new methods and approaches in treating these children. Special attention is paid to nonconventional methods of therapy.

The neonatology department of the pediatrics research institute of the Academy of Medical Sciences of Russia has tested the food additive Provit provided by the Primavera Medica Center. The preparation includes 4 amino acids and is packed in capsules of either 500 mg. The capsule content is diluted in water and given 3 times a day 20-30 minutes prior to feeding. The Provit dosage is calculated according to the body mass. The treatment scheme includes 3 courses of 10 days each with a 5-day interval between the courses.

Provit was administered on the background of conventional treatment that comprised drug therapy and a set of rehabilitative procedures (massage, remedial gymnastics, therapeutic swimming and exercises in water).

The objective of our study was to determine the optimal dose for premature babies, detect side effects, work out indications for the use of the drug concerned.

The effectiveness of treatment was controlled by a daily physical checkup, the assessment of the neurologic status and psychomotor development as well as by neurosonography.

The trial group was made up of 20 children. All of them were born from mothers with an aggravated obstetric-gynecological case history, from pathologic pregnancies (toxicosis of the first half and anemia of various severity degree, threatened pregnancy interruption at different times, neuropathy of a moderate-severe and severe course, exacerbation of chronic renal diseases and infectious-inflammatory diseases of the women's genitals; acute respiratory viral infections; chorionamnionitis was diagnosed in 1 female patient) and had pronounced perinatal CNS impairment that was expressed by CNS suppression symptoms, increased nervous-reflex excitability, hypertension-hydrocephaly syndrome, spasmodic potential syndrome of vegeto-visceral disorders, regurgitation syndrome, muscular dystonia; intracranial hemorrhage was diagnosed in 2 babies in the neonatal period; all the children underwent treatment in the in-patient unit of the neonatology department (ND). Seven infants were full-term and 1

The comparison group included 9 children all of whom were cared for in the neonatology department; like children of the trial group, they had a pronounced CNS lesion, were born from mothers with an aggravated obstetric-gynecological history and from pathologic pregnancy. One infant was born in time operatively (flat obstetrical forceps), 9 were premature and born in gestation times varying between 31 and 35 weeks. The weight at birth was in the 1.200-3.560 kg range. Three babies were examined in the follow-up history 1.5-2 months after discharge.

In assessing the data presented in the summary table, it can be stated that prior to treatment all the children had, to a certain extent, a manifest reduction of inborn motor and tonic reflexes (supporting, automatic walking, crawling, Galant, Perez, labyrinthine tonic, symmetric tonic and asymmetric tonic reflexes); half of the children examined had no sucking reflex.

It should be pointed out that the neck symmetric tonic reflex in the lying position and vertical body posture was activated following the start of treatment. In this case the legs of the children were always fully extended in all joints while the tone of the flexor muscles of upper limbs was increased. This proves that the supporting reaction that was realized earlier that the crawling reflex was performed at the expense of an increased tone of the extensors of lower limbs; when the tone of the extensor muscles decreased, then there was a decussation (crossing) of the legs, that disappeared later. Moro's reflex was extinct by the 3rd course of drug treatment.

The Graefe symptom proved to be the most persistent: following the 1st course, it tended to increase, in some children it disappeared towards the end of treatment, however. The grasp reflex was also pronounced in all the children of the trial group. Half the children of this group lacked the sucking reflex at the beginning of treatment, but already during the 2nd course of treatment it was significantly more active; by the close of the 3rd course all the children sucked independently except for one child that was fed through the feeding tube. Look fixation developed during the first month of life. Humming in profoundly premature children emerged during the first 2 months of life. Provit proved to be most effective in profoundly pre-term and immature children; its administration in the first week of life produced the maximum effect.

It should be emphasized that 4 children from the trial group developed side effects. One child with CNS suppression syndrome developed, on the background of Provit intake, floating movements of the eyeballs, and the emerging positive dynamics disappeared. In 3 children who received Provit there were a sharp increase of CNS excitability symptoms, a loud irritated cry, rigidity of occipital muscles, increased tremor of the hands and the chin; more frequent regurgitation was recorded in 1 child. On completion of the first course, during a 5-day break, there was a tendency towards improvement, but in 2 cases the resumed drug intake led again to an increase in neurologic symptomatology. For this reason the drug intake was discontinued in 2 cases and in 1 case it was continued at a smaller dosage which produced a favorable clinical effect. Neither allergic reactions to Provit nor stool disorders were reported.

Comparing these data with those of repeated checkups of the children from the comparison group, we can point out that in the latter neurologic status disturbances were longer lasting. These disturbances included a delayed reduction of the tonicity of the extensors of low limbs, the formation of the supporting, crawling, automatic walking reflexes. Moro's and Graefe's syndromes were retained for a long time.

The case discussed below is a typical example of effective treatment.

A girl from the second pregnancy of a bipara aged 32 years. No somatic diseases were recorded. The pregnancy in question progressed with toxicosis in the first half; up to 12 weeks nausea and morning vomiting without loss of the body mass were reported. In the second trimester pregnancy proceeded against the background of anemia with a decrease of Hb down to 100 g/l. At the time of 29 weeks, the ultrasound recorded chorioamnionitis, which led to in-patient therapy. Due to powerless labor, the delivery was premature and performed by cesarean section.

The girl was born prematurely in the head presentation at the gestation time of 35 weeks. The evaluation was 4/7 points according to the Apgar score. Omniotic fluid was clear, with odor. Following delivery, the condition was severe and required resuscitation procedures and injection of correcting solutions immediately in the maternity department.

In the course of the first day of her life the girl developed a VPR, at the height of which dyspnea was 90/min. The weight at birth was 2.650 kg, the height being 47 cm, head circumference 35 cm and chest circumference 33 cm.

Upon admission to the department the condition was grave: cerebral circulation impairment of 2nd-3rd degree; violent CNS depression; hypotonies and hyporeflexias; frog's pose; absence of independent sucking; nonretention of warmth; pronounced acrocyanosis and cyanosis of the nasolabial triangle that increased at load. Emergence of mottling of skin. Absence of active movements. Occasional spasmodic twitching of limb muscles. Sharply declined muscular tonicity; oral automatism reflexes (sucking, Babkin's, search and lip reflexes) were not induced. The grasp reflex was negative. The crawling, supporting, automatic walking, Galant's and Perez' s reflexes were negative. The asymmetric neck tonic reflex was pronounced. The girl did not open her eyes, nor did she react to examination. ECHO-EG recorded an intracranial hemorrhage into the region of the vascular plexus.

The patient received Provit from the 7th day of life on. Provit administration produced essential activation since the first day of drug intake. Active movements appeared, the girl began to open her eyes; sometimes vertical nystagmus was noted. Beginning of independent sucking: the girl sucked out the entire portion at the close of the first course of treatment. Waking time increased. Positive dynamics was recorded in the neurologic status; the grasp reflex was induced; paresis of the hands was retained; the muscular tone remained diminished, yet non so grossly. The supporting reflex was positive; there was an emerging trend to step movements; the Galant's, Perez's and crawling reflexes were slightly positive. The tonic reflexes, that is, the labyrinthine neck tonic and asymmetric neck tonic reflexes, were induced, yet they were less marked.

At the start of the second course of Provit treatment, mottling of skin still remained. The girl was cared for in bed and did not regurgitate. Her muscle tone was close to normal; the grasp reflex got normalized, no ophthalmic pathologic symptoms were evoked; the supporting, automatic walking and crawling reflexes were positive, yet Galant's and Perez's reflexes got rapidly extinct. The patient fixed the look well. According to ECHO-EG, there were no disturbances in that respect.

At the age of 1 month the girl was discharged and received the 3rd course of Provit treatment back home.

In the follow-up story ( catamnesis) when she was 3 years old the girl was examined. There was a positive dynamics in the neurologic status, yet she was excitable, performed a large number of chaotic movements and retained a slight paresis of the hands. There was a tendency to an increased tone in the flexors of the arms and muscular dystonia. The grasp reflex was positive. She held her head well, raised it in the supine position. The crawling reflex was positive, equally positive was the supporting reflex with feet crossing; the automatic walking reflex was also positive. Sharply pronounced was the labyrinthine tonic reflex to the toes of the feet as well as the asymmetric tonic reflex. Mental development corresponded to her age-linked development.

Aged 3.5 months, the girl was admitted to a rehabilitation center where Provit treatment was continued; it was combined with a set of rehabilitative procedures (massage, remedial swimming, exercises in water, etc.). At the moment of discharge a manifestly positive dynamics was registered. Neurologically, she became quieter; mottling was less marked; she held her head well and raised the head from the supine position, turned to the side, showed interest in toys, hummed a lot and played all alone for a long time. The grasp reflex was positive; a somewhat increased tone in the flexors of the arms was recorded. At the start of treatment, the supporting reflex covered tiptoes and then, before discharge, the whole foot; prior to discharge, step movements emerged; the crawling reflex was positive. At admission, the ECHO-EG recorded a dilation of the lateral ventricles maximally up to 15 mm in the occipital horn. At discharge, a positive dynamics with a decreased volume of the ventricles up t

In comparing these data with those obtained from repeated examinations of the children from the comparison group, it can be stated that the latter had more lasting neurologic status disturbances similar to those discussed above. Among them were a delayed drop in the tonus of the extensors of low extremities, the formation of the supporting and crawling reflexes; Moro's, Graefe's tonic reflexes were registered at the end of the 3rd month of observation.

The comparison of the clinical picture of the two groups concerned also demonstrates that the normalization of the neurological status of the 1st group of children treated with Provit proceeded gradually. At the beginning of the second and third months of life, the children who did not receive Provit developed a slight increase in the hypertensive syndrome, an activation of tonic reflexes, an occasional recovery of the extinct or a strengthening of the available spasmodic syndrome. In the context of intensive recovery therapy these phenomena vanished 3-6 weeks later.

Thus, the testing of the amino acid compound Provit has revealed both its sufficient therapeutic efficacy in the comprehensive early rehabilitation of pre-term children with perinatal CNS impairment and the absence of side effects on the immature organism of the child.


 
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