Efficacy of a galactogogue containing silymarin-phosphatidylserine and galega in mothers of preterm infants: a randomized controlled trial.

BACKGROUND/OBJECTIVES: Human milk (HM) is the best possible food for all infants, especially for preterm ones, but lactation and breastfeeding are very difficult for mothers of preterm babies and high rates of breastfeeding difficulties have been reported. Our aim was to investigate the efficacy of a galactogogue containing silymarin-phosphatidylserine and galega in increasing milk production during the first month after delivery in a population of mothers of preterm infants. SUBJECTS/METHODS: Mothers of infants with gestational age (GA) between 27+0 and 32+6 weeks were enrolled in this prospective, double-blind, randomized trial and were randomly allocated to receive either the galactogogue containing silymarin-phosphatidylserine and galega, 5 g/day (galactogogue group, GG), or a placebo, 5 g of lactose per day (placebo group, PG) from the 3rd to the 28th day after delivery. RESULTS: Fifty mothers were included in each group. General characteristics of mothers and pregnancies were similar. Milk production was significantly greater in the GG at the 7th day of life and at the 30th day of life. Daily milk production from the 7th to the 30th day of life was 200 (110-380) ml in the GG vs 115 (60-245) ml in the PG (P<0.0001). The total production of milk during the study period was significantly higher in the GG (6523±5298 ml vs 4136±4093 ml; P<0.02). At the end of the study, 45 mothers of the GG were able to reach the target of milk supply of 200 ml/day compared with 25 mothers of the PG (P<0.01). No adverse reactions were noticed in the study groups. CONCLUSIONS: Silymarin-phosphatidylserine and galega increased milk production in mothers of preterm infants without any significant side effects.

Effectiveness of a prematurity-based protocol for management of infants born to mothers with Group B Streptococcus colonisation.

The aim of this study was to validate the efficacy of a protocol for the management of infants born to colonised mothers with Group B Streptococcus (GBS). We studied a cohort of newborns admitted at the A. Gemelli University Hospital between May 2006 and December 2009. A total of 1,108 were newborns of mothers with GBS; 178 were children of mothers with unknown GBS status. Newborns were managed according to the care protocol in use at our division. Infected infants were born to mothers who underwent inadequate intrapartum antibiotic prophylaxis (IAP). No mother with complete IAP had an infected newborn. The incidence of invasive GBS infection in newborns of mothers with GBS was 0.4% and in newborns of mothers with unknown GBS status was 2.2%. Only 17.4% of newborns of mothers with GBS had risk factors. The complete IAP should always be performed regardless of the presence or the absence of risk factors. The care protocol applied offers successful management of the newborns of mothers with GBS, based on the correct execution of IAP, considering as a primary risk factor, the gestational age of < 35 weeks.

Spontaneous neonatal pneumomediastinum: radiological or clinical diagnosis?

Spontaneous neonatal pneumomediastinum (PNM) is associated with the aspiration of blood or meconium and birth-related trauma and it seems to be more frequent in post-term newborns. It is generally asymptomatic, but it is occasionally accompanied by mild tachypnoea. Only rarely, it requires oxygen therapy or develops into pneumothorax. To evaluate the relationship between the radiological and clinical diagnosis in this uncommon problem, from January 2005 to August 2009, 35 newborns with spontaneous PNM were enrolled in the study. Treatment protocol provides for execution of a chest X-ray, clinical check, SatO(2) and heart rate monitoring. Clinical diagnosis was accomplished particularly early, within the first 24 h of life. Paraphonic and distant tones discovered by cardio-auscultatory exam disappeared within the following 72 h. A total of 28 newborns were asymptomatic (80%); seven were symptomatic (20%); five had transient tachypnoea of the newborn; two developed an RDS, with Silverman score ≥ 3 and required O(2) therapy. It is necessary to affirm the importance of early diagnosis of this condition, carrying out careful monitoring of newborns at risk, to begin timely therapeutic treatments, as oxygen-therapy and to heighten alertness for complications, such as pneumothorax.

Comparison between two treatment protocols with recombinant human erythropoietin (rHuEpo) in the treatment of late anemia in neonates with Rh-isoimmunization.

OBJECTIVE: [corrected] The Rh-hemolytic disease can lead to a late anemia by hemolytic and hyporigenerative mechanism. We compared the effectiveness of rHuEPO in two care protocols that differ for doses of rHuEPO administrated and for timing of administration. METHODS: A cohort of 14 neonates was investigated. The neonates were treated with two different protocols. Protocol A: a dose of 200 U/kg/day of rHuEpo administered subcutaneously starting from the end of the second week of life; Protocol B: a dose of 400 U/kg/day of rHuEpo administered subcutaneously starting from the end of the first week of life. RESULTS: The hematocrit values in the protocol A group decreased during treatment (32,5% vs 25,2%), whereas the hematocrit value in protocol B group remained almost stable (38,7% vs 42,8%). The mean numbers of platelets remained stable in both groups while neutrophils increased in protocol A group and decreased in protocol B (p<0,05). Reticulocyte count increased during treatment in both groups, although only in protocol B group it was statistically significative (p<0,05). CONCLUSIONS: Our results suggest a similar efficacy between the two treatment protocols. Increasing doses of rHuEPO do not seem enhancing their effectiveness and the incidence of side effects.

[Breastfeeding and infectious diseases: state of the art]. / Allattamento al seno e malattie infettive materne: stato dell'arte.

Despite the well-known nutritive, psychological, immunological and economical benefits of breast-feeding, some contraindications exist, such as some mother infectious diseases transmitted through the breastfeeding itself. The risk of transmitting an infectious agent through breast milk seems to be relatively low, except for some virus diseases (CMV HIV), for some invasive bacteria forms (Salmonella typhimurium and Brucella) and for the presence of abscesses and mastitis. In some mother infectious disease, a correct hygiene allows the continuation of breastfeeding without risks for the infant, whereas in other cases it is recommended to breastfeed for the role of defence carried out from specific antibodies contained in the breast milk. Therefore, the decision of interrupting the breastfeeding may be done only after comparing risks and benefits, considering current knowledge on transmission of infectious pathologies.

[Fetal and neonatal outcomes in infants of mothers with TSH receptor antibody positivity in pregnancy]. / Esiti feto-neonatali nei figli di madri con positivita' degli anticorpi anti-recettore del tsh in gravidanza.

OBJECTIVES: To know the mother's frequency with TRAb (TSH receptor antibodies) positivity during pregnancy in the population afferent to Agostino Gemelli Hospital in the five years 2002-2007 and the itself antibodies's role determining fetal and neonatal symptoms. MATERIALS AND METHODS: We performed a prospective analysis with maternal and neonatal variables detection in 16 couples mother-newborn with TRAb positivity during the pregnancy. The method to dose neonatal TRAb is ELISA (enzyme linked immunosorbant assay). RESULTS: The prevalence of newborns of mothers with TRAb positivity during pregancy results 0.1 per thousand (16/16783). The prevalence of neonatal hyperthyroidism, clinical and biochemical, in the studied population results especially elevated equal to about 30% (5/16). The 5 newborns are born to mothers with Basedow disease with TRAb serum levels greater than TRAb levels of newborn without hyperthyroidism: 2 are showed the symptoms of clinical hyperthyroidism and 3 a transient biochemical hyperthirodism. 3 newborns with hyperthyroidism among 5 are born to mother undergo thyroidectomy with L-tiroxina teraphy during the pregnancy. Then the newborns of thyroidectomized mothers also many years before the pregnancy must be considered high risk of developing neonatal hyperthyroidism because of long-lasting persistence of mother's TRAb. The neonatal hyperthyroidism, clinical and biochemical, appears later in newborns of mothers using antithyroid drugs. The pharmacological treatment of neonatal hyperthyroidism was difficult to standardize and highly individualized. CONCLUSIONS: Although the neonatal hyperthyroidism is a very rare disease it is essential to apply specific protocol assistance, both during pregnancy and the neonatal period, in the presence of maternal TRAb positive for the risk of serious cardiovascular complications.

Neonatal hyperthyroidism: neonatal clinical course of two brothers born to a mother with Graves-Basedow disease, before and after total thyroidectomy.

BACKGROUND: About 1-2% of infants born to mothers with Graves' disease or Hashimoto's thyroiditis develop neonatal hyperthyroidism because of transplacental passage of IgG stimulating TSH receptors (TRAb). OBJECTIVE: To evaluate the effect of maternal total thyroidectomy on neonatal clinical course. METHODS: We describe two brothers born to a mother with Graves' disease, before and after total thyroidectomy. RESULTS: The first child showed persistent tachycardia, the presence of TRAb and a laboratory pattern of hyperthyroidism. Lugol's solution was started and then propylthiouracil was added. Digitalis, furosemide and diazepam were necessary for treatment of heart failure, hypertension and irritability. On the 70th day of life, hormone serum levels normalized and treatment was interrupted. TRAb normalized by the third month of life. The second infant was born 2 years after the mother underwent total thyroidectomy. In spite of a laboratory pattern of hyperthyroidism and positivity to TRAb, he showed only considerable weight loss, and no therapy was required. CONCLUSIONS: TRAb may persist after total thyroidectomy: clinical and instrumental follow-up of the newborn is recommended.

[Evaluation of C reactive protein and others immunologic markers in the diagnosis of neonatal sepsis]. / Validità della proteina C reattiva e di altri marker immunologici nella diagnosi della sepsi neonatale.

Neonatal sepsis occurs from 1 to 21 newborns out of 1 000 live births with mortality rates as high as 30% up to 69%. The most important risk factors are prematurity, low birth weight, invasive medical procedure and prolonged hospitalization in neonatal intensive care units. An aimed and restrictive antibiotic therapy has an outstanding importance to reduce both morbidity-mortality rates and multiple drug-resistance. Generally, preterm newborns present nonspecific clinical signs of infection. The use of high sensitivity infection markers and a negative predictive value (near 100%) are important to distinguish infected and noninfected patients before the culture results and to verify adequacy and duration of antibiotic therapy. This article reviews the immunologic function and practical use of C reactive protein (CRP) and other markers in the diagnosis of neonatal sepsis. While CRP is a specific late infection marker, cytokines, cell surface markers and procalcitonin (PCT) are early infection markers. The use of multiple markers as CRP, PCT, IL-6, IL-8, CD64, CD11b is useful both to early (24-48 h) diagnose of neonatal sepsis, and to monitorate the antibiotic treatment while waiting for the results of cultural examinations.

[Prebiotics and probiotics in infant nutrition]. / Prebiotici e probiotici nell'alimentazione del lattante.

Many studies have recently analyzed the modulation of the intestinal microflora showing a benefic effects reducing the number of enteritis, improving the oligoelements absorption and stimulating the immunitary system. To do so three way are available: the use of prebiotics, the use of probiotics and the symbiotic way. Prebiotics are non-digestible oligosaccharides that can stimulate selectively the growth bifidogenus bacteria. Probiotics are dietary supplements made of live micro-organisms which improve the microbial environment of the gut. In this review literature is examined the possible efficacy of prebiotics and probiotics in the pediatric age; however, the studies available do not permit to obtain definitive conclusions.

Mild and transient neutropenia in an infant of mother with Wegener's granulomatosis.

A case of a pregnancy occurring in a woman with previously diagnosed Wegener's granulomatosis and the following neonatal follow-up are described. Complete clinical and laboratory disappearance of disease activity was achieved by steroid treatment before pregnancy. The newborn was followed up for 6 months; he always showed normal clinical and laboratory exams, except a mild and transient neutropenia.

Higher urinary excretion of essential amino acids in preterm infants fed protein hydrolysates.

AIM: Protein hydrolysates have been introduced in preterm formulae, but it is not clear whether they are needed for the feeding of preterm infants. We designed a randomized, controlled trial to test the effects of a preterm formula with hydrolysed cow's milk proteins on short-term growth and urinary and plasma amino acids levels. METHODS: Infants with a birthweight < or = 1750 g and gestational age < or = 34 wk fed a conventional preterm infant formula (formula B) or a hydrolysed formula (formula A). Weight was measured daily; length, head circumference, mid-arm circumference and total skinfold thickness were measured weekly. Blood and urine were analysed for amino acid concentrations at start, 14 and 28 d. RESULTS: Twenty-one infants met the criteria for randomization. The daily feeding volumes were: formula A 172.8 +/- 5.6 vs formula B 170.1 +/- 2.8 ml/kg/d. Infants fed with formula A showed slower weight gain (17.4 +/- 3.4 vs 20.5 +/- 3.3 g/kg/d; p = 0.045) and lower mean change in Z-scores for weight (-0.18 +/- 0.16 vs 0.00 +/- 0.09; p = 0.009) and for head circumference (-0.06 +/- 0.13 vs 0.06 +/- 0.13; p = 0.049). After 14 d, infants receiving formula A had statistically significant higher urinary levels of essential amino acids compared to infants receiving formula B. CONCLUSION: Our results support the hypothesis of less nutritional value of hydrolysed versus conventional preterm formulae. Higher renal excretion of essential amino acids may be one of the mechanisms involved. These findings must be confirmed by further studies with larger sample sizes and protein hydrolysates with different degrees of hydrolysis.

[Effects on growth, tolerability and biochemical parameters of two different human milk fortifiers in very low birth-weight newborns]. / Effetti sull'accrescimento, sulla tollerabilitlà e sui parametri biochimici dell'uso di due tipi di fortificanti del latte materno in neonati di peso molto basso.

OBJECTIVES: The aim of the study was to compare a group of very low birth-weight infants feeded with a preterm formula with two other groups feeded with human milk and two different fortifiers. METHODS: 30 preterm newborns with birth-weight < 1.500 g, admitted to the Neonatal Intensive Care Unit (NICU) of Department of Neonatology of Catholic University of Rome were randomized for three different feeding groups: total enteral nutrition with HM fortified with Enfamil Human Milk fortifier or with Eoprotin, compared to a group feeded with Similac 24 preterm formula. Statistical analysis was performed using the two-way analysis of variance (ANOVA). RESULTS: During the study and at the end we found a growth rate for weight, cranial circumference and lenght similar to the fetal standard growth rate in the third trimester of pregnancy in all the three groups. Fortified HM was well tolerated. No pathologic value of the biochemical parameters studied was found. Higher level of serum phosphorus in spite of significantly lower intakes of phosphorus occurred in fortified HM feeded neonates, as if there was a better availability of this nutrient in HM. CONCLUSIONS: This study demonstrates the role of fortified HM as a good alternative to the preterm formula.

[Neonatal lupus: different clinical neonatal expression in siblings]. / Lupus néonatal: une fratrie de nouveau-nés avec différentes expressions cliniques.

Neonatal Lupus Syndrome is a rare disease caused by placental passage of maternal autoantibodies. Pathogenesis is partially unknown and many clinical manifestations are possible. We report on newborn siblings who presented with different symptoms of Neonatal Lupus Syndrome. One patient presented with congenital heart block and another with hepatic and haematologic involvement. Cases of Neonatal Lupus among siblings are very rare, because of the high risk of pregnancy in affected women. Various clinical expressions may be explained by a different specificity of Anti-Ro autoantibodies among siblings. The reported cases are commented with regard to recent literature, trying to explain their pathogenesis.

Cerebral ultrasound findings in neonatal lupus syndrome.

A prospective study was performed enrolling 11 newborns with neonatal lupus syndrome (NLS) and 22 control newborns to investigate cerebral ultrasound (US) anomalies and their relationship with clinical neurological signs and laboratory findings. Cerebral US detected a significantly higher incidence in the study group of both subependymal pseudocysts (SEPC) and subependymal hemorrhage (SEH), neither of which correlated to autoantibody levels. All infants had completely normal neurological examinations both at birth and follow-up. The etiopathogenesis of central nervous system findings in NLS is discussed. US evaluation identified minimal anomalies compatible with favorable outcome: further studies are necessary to investigate the possible long-term sequelae, pathogenesis and spectrum of cerebral US findings.

[Long-term treatment with cabergoline in pregnancy and neonatal outcome: report of a clinical case]. / Trattamento protratto con cabergolina in gravidanza ed esiti neonatali: descrizione di un caso clinico.

Hyperprolactinemia is one of the causes of sterility. Cabergoline is indicated in cases resistant to bromocriptine, but, usually, its administration is interrupted at the beginning of the pregnancy. A case of prolonged treatment with cabergoline during pregnancy is reported, without teratogenic effects on the fetus.

[Alimentary strategies in the neonatal period in the prevention of allergies]. / Strategie alimentari nella prevenzione dell'allergia in età neonatale.

The Authors report an update relative to the dietetic prevention strategies in the high allergic risk subject, as proposed from more recent literature. The babies with a familiar history of atopia are defined as population with allergic risk. The Authors examine the role of early exposure to cow's milk formulas and maternal diet during breast-feeding as risk factors for allergic symptoms in such babies. Moreover, they examine the indications for hydrolisated milk (partial and extensive) formulas and soy milk formulas use, as reported in published Meta-analysis and official statements of several Scientific Associations. They conclude that beyond the undoubted preventive role of exclusive breast-feeding in the first 4-6 month after birth, and of the extensively hydrolisated formulas, there are many concerns about the role for partially hydrolisated formulas and soy formulas. The Authors claim for multicentric methodologically correct trials in order to clear the controversies.

Neonatal outcome of spontaneous and assisted twin pregnancies.

OBJECTIVES: Over the last 10 years, diffusion of assisted reproduction techniques (ovarian stimulation, IVF, GIFT) has led to an increased incidence of multiple pregnancies and consequently, of the related obstetric-neonatal problems. In this study, multiple births have been studied, with particular reference to the twin births occurring in the Gemelli hospital, Rome. The hospital is also a reference centre for obstetric pathologies and infertility treatment. In particular, attention has been focused on neonatal outcome, comparing twins born from spontaneous and assisted pregnancies. STUDY DESIGN: 228 neonates from spontaneous twin pregnancies and 32 from assisted twin pregnancies were taken into consideration with regard to: premature birth, low birth-weight, intrauterine growth retardation, weight discordance, Apgar score, major neonatal diseases, and mortality. RESULTS: Results showed a significant higher incidence of prematurity and low birth-weight, as well as a significant lower gestational age, occurring more frequently in twins resulting from assisted pregnancies than in twins from spontaneous pregnancies. Furthermore, the incidence of severe depression at birth and respiratory disease was significantly higher in twins from assisted pregnancies than in those from spontaneous pregnancies, despite similar gestational age and birth-weight.

Transient effect of granulocyte colony-stimulating factor in allo-immune neonatal neutropenia.

The effect of recombinant human granulocyte colony-stimulating factor (rhG-CSF) administration at 10 microg/kg/day for 15-30 min over 3 consecutive days in 3 preterm neonates with allo-immune neonatal neutropenia (ANN) is reported. Patients 1 and 2 had antibodies against antigen NA2, while patient 3 had antibodies against NA1. All neonates developed a rapid increase in absolute neutrophil count which reached the normal range within 48 h (from 75-640/mm(3) to 2,520-4,700/mm(3)). However, 23-25 days later, all 3 neonates relapsed into a second phase of severe neutropenia (408-870/mm(3)). Antibodies against neutrophil antigens were still positive during this period. This second-phase neutropenia persisted for 20-30 days and resolved spontaneously. It may be possible that when rhG-CSF is administered within a short time after birth in neonates with ANN, its effect is exhausted before the concentration of circulating antibodies decreases, with the result that a second phase of neutropenia can be expected.

Do recombinant human erythropoietin and iron supplementation increase the risk of retinopathy of prematurity?

Comparing a group of infants treated with recombinant erythropoietin and iron supplementation to a group of control infants, no difference was observed concerning the transfusion need. The incidence of retinopathy of prematurity was significantly higher in the treated group. These data need to be confirmed in randomized controlled studies.