Scopul studiului: Aprecierea impactului unor tehnologii medicale bazate pe dovezi ştiinţifice în creşterea supravieţuirii prematurilor cu greutate mică şi foarte mică la naştere.
Sarcinile studiului:
1. Dinamica mortalităţii neonatale precoce pe parcursul anilor 2000-2010.
2. Metodele de stabilizare respiratorie a copiilor prematuri: Suport respirator nasal cu presiune pozitivă continuă
la expir (NCPAP) precoce vs surfactant vs ventilare mecanică (VAP).
3. Eficacitatea terapiei antenatale cu corticosteroizi asupra structurii morbidităţii şi mortalităţii copiilor prematuri
în secţia Reanimare şi Terapie Intensivă a IMSP IMşiC (RTInn).
4. Influenţa implementării modifi cărilor resuscitării neonatale din 2010 asupra morbidităţii neonatale pe parcursul anului 2012.
5. Studiul morbidităţii şi mortalităţii neonatale în 2 maternităţi de nivelul 3 din 2 ţări vecine “Republica Moldova
şi regiunea Moldova din România” cu aceleaşi dotări.
Lotul de sudiu: Prematurii cu termenul de gestaţie ≤ 32 săptămîni de gestaţie (sg) şi/ sau prematurii cu masa la
naştere ≤ de 1500 g care s-au născut pe perioada anilor 2000- 2012. În studiu au fost incluşi 1948 prematuri.
The aim of the study: The assessment of the impact of some medical technology based on scientific evidence in
increasing survival of premature infants with low and very low birth weight.
Objectiv of the study:
1. The dynamics of early neonatal mortality during the years 2000-2010.
2. The methods of respiratory stabilization of premature infants: early NCPAP (Nasal Continuous Positive Airway
Pressure) vs. surfactant vs. mechanical ventilation (APV).
3. The effectiveness of antenatal corticosteroid therapy on the structure of morbidity and mortality of premature
infants in Resuscitation and Intensive Care Unit (NICU) of the Institute for Mother and Child Health Care.
4. The influence of implementing the neonatal resuscitation changes from 2010 on neonatal morbidity during the
year 2012.
5. The study of neonatal morbidity and mortality in 2 maternity hospitals of level 3 from 2 different countries –
Republic of Moldova and region of Moldova in România, with the same facilities.
Study group: Premature infants with gestation period ≤ 32 sg (weeks of gestation) and/or premature infants with birth
weight of ≤1500 g who were born during the years 2000-2012. In the study were included 1948 premature infants.
Results:
9 Once, with increasing the number of premature infants with birth weight ≤ 1500 g admitted to the NICU from
4.8%, 3% up to 10.8%, the survival of these premature infants increases: with birth weight less than 999 g and gestation period ≤ 28gw from 33.3% to 51%, with birth weight less than 1499 g from 64.3% to 87.7%. The same trend was
observed also in other groups of children – a steady increase in neonatal survival rate.
9 The data analysis of children admitted in NICU, showed that the rate of children transported “in utero” is
growing steadily: if in 2008 were transported 66% of newborns with birth weight up to 1500g, in 2012 the rate of these
children grow up to 78.3%. 9 HMD (hyaline membrane disease) incidence decreased once with antenatal administration of steroids -72.8%
of children born from mothers without antenatal prophylaxis of respiratory distress syndrome (RDS) with corticosteroids up to 32.8% in the group of children whose mothers received the full and fair cure with corticosteroids (p < 0.05).
9 Duration of oxygen therapy was lower in the group of children whose mothers received full treatment with dexamethasone (29.5 ± 17.5 hours) and grows in the group of children whose mothers did not received antenatal steroids
(45.5 + 61,9 hours) (p < 0,01),
9 The need for surfactant and respiratory support with APV (artificial pulmonary ventilation) increased in the
group of children whose mothers did not received prenatal course of steroids (45.5%).
9 The average hemoglobin level at admission in NICU: in the group of premature infants where was applied the
milking of umbilical cord - 190 ± 3.8 g/l compared to the group of premature infants whom was not applied the milking
of umbilical cord – 156 ± 3.6 g/l (p <0.01).
9 The average blood pressure at admission in NICU: the group of premature infants where was applied the milking
of umbilical cord - 35 ± 3 mmHg, comparing to the group of premature infants in whom was not carried out the milking of
umbilical cord - 25 ± 2 mmHg (p = 0.02).
9 On the 10th day of life no the child in the group of premature infants where was applied the milking of the umbilical
cord did not required a red blood cells transfusion.
9 The same was observed for a shorter period of lung mechanical ventilation in the group of premature infants in
whom was applied the milking of the umbilical cord - 3.1, as compared to 4.2 in the group of premature infants where was
not applied the milking of the umbilical cord (p <0.01).
9 In the group of children who were received and resuscitated directly into heat protecting sheet, then transferred
to NICU in a specialized for transportation servo-control incubator, temperature at birth was 37.0± 0.3°C, and the
temperature at admission in the NICU was 36.9 ± 0.3°C (p < 0.001). In the premature group who at birth were not
placed in a heat protecting sheet, the average temperature at birth is 36.9 ± 0.3°C, but the temperature at admission in
the NICU was 36,0 ± 0,3°C.
9 Early keeping of alveolar expansion with a positive end-expiratory pressure was insured by NCPAP, resulting in
decreasing the incidence of exogenous surfactant administration and reduction of routine intubation, because comparative
statistical results related to respiratory support between the children who were placed to early NCPAP and the group of
premature with surfactant administration in the first hour of life, were equivalent too. The study showed that there was no
statistically significant difference between the pneumothorax incidence and pulmonary emphysema between these groups.
9 Late administration of exogenous surfactant was associated with a longer period of mechanical ventilation and
needs of a higher concentration oxygen, on the 14th day of life in the group of premature infants who were given curative
surfactant in the first 12 hours of life - 33.3% children needed breathing support, including 6.8% (children with 3 doses
of surfactant) APV with FiO2
> 30%. In the group of children whose treatment of HMD consisted of APV, on the 14th
day of life 26.7% children required APV with FiO2
> 30%.
9 Retrospective study conducted in 2013 on mortality and neonatal morbidity in 2 maternities of 3rd APV level in 2
countries, Moldova and Moldova region in România, over the past 3 years, with the same socioeconomic indices and with
the same facilities showed that in Moldova, NCPAP, as a method of prophylaxis and treatment of RDS was more commonly used (42.3% vs. 30%). The association of ventilation through NCPAP with APV was more common in Iasi, Romania
(35.4% vs. 24.6%). Significantly lower use of mechanical ventilation was correlated with the frequent use of the INSURE
(intubation-surfactant-extubation) method for treatment of the respiratory distress syndrome.
The study proved the direct correlation between low birth weight (≤999g) with an increased risk of death (exp (β)-
OR = 4.84, p < 0.001).
The surfactant administration is an important prediction factor in the decline of death rate (exp (β)-OR = 0.601, p = 0.0450).
Mechanical ventilation associated with NCPAP significantly lowers the risk of death (exp (β)-OR = 0.22, p = < 0.001).
Conclusions:
¾ Implementation along with the regionalization of the perinatal service and increase of the "in utero" transportation rate has increased the number of premature babies with birth weight <1500 g admitted to NICU.
¾ Low birth weight is directly proportional to the high risk of death.
¾ In increasing the survival of premature infants up to 51% an obviously impact has antenatal administration
of the corticosteroid treatment for prophylaxis of RDS, implementation of the Protocol of resuscitation and care after
resuscitation for extremely premature babies (with gestation period 22-26gw), through the prevention of anaemia, hypotension, hypothermia, as well as by installing a adequale diuresis in the first 24 hours of life.
¾ HMD incidence decreases with antenatal administration of steroid treatment. Duration of oxygen therapy is
lower in children whose mothers received full cure with dexamethasone. The need for surfactant and respiratory support with APV is higher in children whose mothers did not receive prenatal steroids cure.
¾ Use of early NCPAP (patent ductus arteriosus) significantly reduces the necessity of surfactant and the costs of
ventilation therapy for premature infants.
¾ Administration of surfactant is an important predictive factor in lowering the death rate.
APV associated with NCPAP significantly lowers the risk of death.
