Effects of Early versus Standard Central Line Removal on the Growth of Preterm Infants with Very Low Birth Weight: A Non-Inferiority, Randomized Clinical Trial.

Very preterm infants are usually supported by parenteral nutrition delivered through central lines (CLs) while progressing with enteral intake, although the optimal time point for their removal is unclear. This study evaluated the impact of the CL discontinuation time on the short-term growth outcomes of preterm infants. A non-inferiority, parallel-group, randomized controlled trial was conducted in four neonatal intensive care units in Poland. Preterm infants with very low birth weight (VLBW) without congenital abnormalities were eligible. Patients were allocated to discontinue central access at an enteral feeding volume of 100 mL/kg/day (intervention group) or 140 mL/kg/day (control group). The study's primary outcome was weight at 36 weeks' postmenstrual age, with a non-inferiority margin of -210 g. Overall, 211 patients were allocated to the intervention or control groups between January 2019 and February 2021, of which 101 and 100 were eligible for intention-to-treat analysis, respectively. The mean weight was 2232 g and 2200 g at 36 weeks' postmenstrual age in the intervention and control groups, respectively. The mean between-group difference was 32 g (95% confidence interval, -68 to 132; p = 0.531), which did not cross the specified margin of non-inferiority. No intervention-related adverse events were observed. Early CL removal was non-inferior to the standard type for short-term growth outcomes in VLBW infants.

Evaluation of the psychological state of patients with advanced cancer and the impact of support on their emotional condition.

AIM OF THE STUDY: The aim of the study was to evaluate the patient's psychological state in the advanced stage of cancerous disease and to assess the effect of sustenance provided by the nursing personnel upon the emotional state of the patient. MATERIAL AND METHODS: The study group comprised 46 subjects treated in palliative care medical wards in Lódz. The data were collected in accordance with the HADS-M questionnaire as well as a self-developed survey. The information obtained was analysed by means of Pearson χ(2) test. RESULTS: The results obtained indicate that most subjects undergo mood aggravation. 76.2% of patients were diagnosed with depressive states. Only 19.6% of the population under investigation showed no signs of anxiety states. The study demonstrates irritation to be yet another unfavourable emotional state coupled with the advanced stage of cancerous disease with as few as 4.4% (4.2%) respondents claiming not to suffer any such symptoms. The patients highly prize the support they receive and it notably improved their well-being. Social support is essential in the advanced stage of the disease. Less severe mental disorders were noted in people who have received all kinds of support.

[Does the spectrum of peri-intraventricular haemorrhages in preterm infants change over the years? Comparison of two cohorts treated in 1998-2002 and 2005-2009].

AIM OF STUDY: Analysis of prevalence and degree of intraventricular haemorrhages in preterm infants treated at the Institute of Mother and Child in Warsaw between 2005-2009.The results were compared with a similar analysis conducted between 1998-2002 in an effort to find an answer to the question regarding definite changes or trends of changes in this pathology over time. MATERIAL AND METHODS: The studied population comprised 350 infants born at 22-34 weeks of gestation, hospitalised between 2005-2009. These infants were compared with 354 infants treated between 1998 and 2002. Haemorrhages was diagnosed on the basis of repeated ultrasounds performed in a standard manner, through the fontanelle, according to classic rules. MR imaging was performed as required. The extent of haemorrhage was classified in stages 1 to 4. In deceased infants the stage of haemorrhage was verified on the basis of autopsy results. RESULTS: The investigations carried out between 2005 and 2009 showed haemorrhages in 174 infants (49.7%). Extensive stage 3 haemorrhages were diagnosed in 45 infants (12.9%),and grade 4 in 35 infants (10,0%). 40 infants (11,4%) died during hospitalization. Autopsy was conducted in 26 deceased infants (65%); in 18 cases (69%) the diagnosis was confirmed and in no case was the diagnosis regarding the extent of haemorrhage changed. Studies carried out in the period 1998-2002 revealed haemmorhages in 248 infants (70%), including stage 3 in 67 infants (19%), and stage 4 in 34 infants (10%). 93 infants died during hospitalisation. Prevalence of all types of peri- intraventricular haemorrhages (PVH/IVH) is currently significantly lower, but the prevalence of extensive haemorrhages of grade 4 has not decreased. The number of deaths has decreased by half, although at present more infants with grade 4 haemorrhages survive. Comparison of prevalence of (PVH/IVH) of all grades in both cohorts of infants born up to 34 weeks of gestation in different periods, i.e. 1998-2002 and 2005-2009, shows a statistically significant decrease. However, the comparison of prevalence of extensive IVH of grade 4, does not show a statistically significant decrease. The percentage of women with threatened pregnancy who recieved corticotheraphy was 64.2%. This is still definitely too low. CONCLUSIONS: 1. Statistically significant decrease in the prevalence and the severity of peri-intraventricular haemorrhage in the analysis carried out between 2005 and 2009 is a positive conclusion. A negative finding is the fact that the incidence of IV degree intraventricular haemorrhage, does not show a falling trend. 2. A fall in the number of deaths in the population of premature infants born in our Department can be the result of significantly improved medical care in the compared groups. 3. In both cohorts still insufficient percentage of pregnant women receiving prenatal corticosteroids in cases of high risk pregnancy, could be linked with unsatisfactory prophylactie perinatal care. This could lead to lack of improvement in the incidence of IV degree intraventricular haemorrhage. 4. The existing data base in Poland on the incidence of PVH/IVH in the risk group, is insufficient for comparison with European Union Countries data in the EuroNeoNet. The significance of this pathology on individual, social and economic levels, creates a need to carry out periodical analysis, at regional level, concerning its incidence, causes and effects.

[Cortisol concentration, hypotension and treatment of cardiovascular insufficiency in the first days of life of very preterm newborns - preliminary report]. / Stezenie kortyzolu w pierwszych dobach zycia a hipotensja i leczenie niewydolnosci krazenia u noworodków skrajnie niedojrzalych - doniesienie wstepne.

UNLABELLED: Hypotension is a serious condition occurring in extremely premature newborns. One of the treatment methods is administration of hydrocortisone. Preliminary study results indicate that this treatment is effective, but it also bears the risk of complications which may result from cortisol level in the bloodstream prior to the treatment. The aim of the study was to find a correlation between blood cortisol concentration levels of extremely premature newborns, their gestational age and the incidence of hypotension. If hydrocorisone administration was required, safety of its use was evaluated. MATERIALS AND METHODS: The study included 35 preterm newborns (< or = 330 weeks of gestation) admitted to the Neonatal Intensive Care Unit (NICU) at the Institute of Mother and Child in the first 72 hours of life during the period between 01.01.2006 and 30.12.2007. Their mean gestational age was 26.2 weeks of gestation (23-30) and the mean weight was 860.3 g (500-1500 g). Exclusion criteria were congenital abnormalities and heart disease with the exclusion of PDA and PFO, as well as cortisol level >1400 nmol/l for the newborns treated with hydrocortisone. Initial serum cortisol level was measured in the umbilical blood or immediately after admission to the NICU. Cortisol level was determined by LIA method using Liason apparatus, and the results were presented in nmol/l. If hypotension was diagnosed (mean arterial blood pressure value <10 percentile for gestational age in mmHg), 0.9% NaCl was used and catecholamines (dopamine and dobutrex)were administered. If the hypotension was not responding to treatment hydrocortisone was administered. During hospitalization echocardiography and cranial ultrasound examinations were performed, assessing main complications: IVH, PVL, SIP, NEC and hyperglycemia (blood glucose concentration >200 mg%). STATISTIC ANALYSIS: Calculations were made with the SPSS v 12.01 statistical software. Chi(2) test, Mann-Whitney and Spearman tests were used. Significance level of alpha <0.05 was applied. RESULTS: A wide dispersion of serum cortisol levels was observed (58.5-3766.5 nmol/l: median - 293.8 nmol/l) and no correlation was found between the gestational age and cortisol level and the incidence of hypotension. Ten infants required hydrocortisone administration (29%). In the tested group intestine perforation was diagnosed in 6 infants (17%). In both groups hyperglycaemia was found in 50% cases. No case of PVL was diagnosed in the studied group. Statistically significant difference was noted regarding IVH grade III and IV. Their incidence was higher in the group with hypotension (48%) as compared to the non treated group (10%). CONCLUSIONS: 1. The dispersion of serum cortisol levels in the first 72 hours in very preterm newborns is wide. No correlation was found between cortisol level and gestational age and the incidence of hypotension in the studied population. 2. In hydrocortisone-treated group no complications such as SIP and PVL were found. The incidence of hyperglycemia was the same as in the untreated group, which may indicate that the treatment is safe. The results need to be confirmed on a larger number of patients. 3. It was confirmed that hypotension is a significant risk factor for IVH. 4. The study needs to be continued in order to increase the population of newborns treated with hydrocortisone. Their long term follow-up will make it possible to assess the safety of this treatment.

[Comparison of the efficacy of ibuprofen and indomethacin in the treatment of patent ductus arteriosus in prematurely born infants]. / Porównanie ibuprofenu i indometacyny w leczeniu przetrwalego przewodu tetniczego u noworodków urodzonych przedwczesnie.

AIM: To assess the efficacy and safety of early treatment with ibuprofen (IBU) and indomethacin (INDO) of patent ductus arteriosus in preterm infants. Prospective study with blind trial. MATERIAL AND METHODS: We studied 35 preterm infants (19 treated with INDO, 16 IBU) (gestation age <33 and birth weight < 1500 g), who had an echocardiographicaly confirmed patent ductus arteriosus (PDA). The infants were randomly assigned in two groups to receive INDO (0.2-0.2-0.2 mg/kg) or IBU (10-5-5 mg/kg) in first 72 hours of life (average 2 days of life). The rate of ductal closure, the need for surgical ligation, side effects, complications, and the infants clinical course were recorded. RESULTS: The rate of ductal closure was similar in two groups (15/19, 80% INDO; 11/16, 69% IBU). 27 infants (15 INDO, 12 IBU) were treated per protocol (3 doses). For remaining 8 infants we stopped treatment due to side effects. In the IBU group the main reason to stop treatment was pulmonary hemorrhage (3/16, 19%) and pulmonary hypertension (1/16, 6%), but in the INDO group it was increased serum creatinine and urea nitrogen concentrations (3/19, 16%) and intraventricular hemorrhage (IVH IV) grade (1/19 5%). In IBU group vs. INDO, urine output decreased (p=0.02), but never before below the level of oliguria (defined as urine output below 1 ml/kg/h). Risk of necrotizing enterocolitis (NEC) grade II was similar in two groups, but only patients treated with INDO showed intestinal perforations (p=ns). They received also postnatal hydrocortisone and we showed near significant tendency (p=0.06) for intestinal perforation in patients treated with INDO and hydrocortisone. There were no significant differences with respect to IVH or PVL between the groups. CONCLUSIONS: The efficacy of ibuprofen and indomethacin in PDA treatment is similar. Treatment of ibuprofen and indomethacin may cause transient renal dysfunction: diminished urine output and increase of serum creatinine and urea nitrogen concentrations. Indomethacin, especially with concomitant treatment with hydrocortisone, may increase the risk of intestinal perforation.