Oral Probiotics Reduce the Incidence and Severity of NEC in VLBW Infants.

Objective.
We evaluated the efficacy of probiotics in reducing the incidence and severity of necrotizing enterocolitis (NEC) in very low birth weight (VLBW) infants.
Patients and Methods.
 A prospective, masked, randomized control trial was conducted to evaluate the beneficial effects of probiotics in reducing the incidence and severity of NEC among VLBW (<1500 g) infants. VLBW infants who started to feed enterally and survived beyond the seventh day after birth were eligible for the trial. They were randomized into 2 groups after parental informed consents were obtained. The infants in the study group were fed with Infloran (Lactobacillus acidophilus and Bifidobacterium infantis) with breast milk twice daily until discharged. Infants in the control group were fed with breast milk alone. The clinicians caring for the infants were blinded to the group assignment. The primary outcome was death or NEC ( stage 2).
Results.
Three hundred sixty-seven infants were enrolled: 180 in the study group and 187 in the control group. The demographic and clinical variables were similar in both groups. The incidence of death or NEC ( stage 2) was significantly lower in the study group (9 of 180 vs. 24 of 187). The incidence of NEC ( stage 2) was also significantly lower in the study when compared with the control group (2 of 180 vs. 10 of 187). There were 6 cases of severe NEC (Bell stage 3) in the control group and none in the study group. None of the positive blood culture grew Lactobacillus or Bifidobacterium species.
Conclusion.
Infloran as probiotics fed enterally with breast milk reduces the incidence and severity of NEC in VLBW infants.(Lin H, Su B, Chen A, et al.  Pediatrics (Jan 2005); 115: 1-4.
Comments: 
 Probiotics, primarily Lactobacillus species, have been used to treat or prevent a variety of GI disorders with variable success.  We now learn that there may be some promise in using this therapy to reduce the risk of NEC in VLBW infants.  Inthe present study, the absolute risk reduction for NEC was 4.2%, which means that 1 case of NEC was prevented for every 24 infants treated.  One note of caution … while no cases of invasive infection from the probiotic organisms were seen in the study population,  there is a case report in the same issue of Pediatrics  that describes 2 cases of Lactobacillus sepsis in older children who were receiving probiotic therapy.  The final word on the safety of probiotic therapy in premature infants will have to await further studies.

Maternal Fever and Neural Tube Defects

Maternal hyperthermia during the first trimester seems to contribute to an increased risk for neural tube defects (NTDs). Animal studies in the 1980s suggested that fever might lead to NTDs; in humans, however, this association was harder to confirm. A case-control study was undertaken to investigate an epidemic of NTDs near the Mexican border in Texas.
Mexican-American mothers of infants born with NTDs in 14 Texas counties during 1995-2000 were compared with randomly selected control mothers, matched by hospital and year, who gave birth to live children without NTDs. About 6 weeks postpartum, the investigators interviewed mothers concerning their prenatal experiences with fevers, febrile illnesses, exposure to heat from external sources, and hyperthermia-inducing activities.
The findings revealed a two- to threefold increased risk for NTDs in the offspring of women who reported prenatal illness with fever; exposure to hot tubs, saunas, or electric blankets; exposure to environments of high heat, such as a hot kitchen; and work or exercise in the sun.
Comments:
Women often do not know they are pregnant at the time the neural tube is closing (i.e., 2 weeks after the first missed period). When congenital anomalies such as NTDs occur, it is important for pediatricians to take a careful history of predisposing environmental causes. There seem to be sufficient data now to indicate that maternal hyperthermiaconveys an increased risk for NTDs. Maternal temperature over 38.5°C (101.3°F) is of concern in early embryogenesis.
(Published in Journal Watch, Pediatrics and Adolescent Medicine January 14, 2005)

Selective head cooling with mild systemic hypothermia after neonatal encephalopathy

Background
Cerebral hypothermia can improve outcome of experimental perinatal hypoxia-ischaemia. We did a multicentre randomised controlled trial to find out if delayed head cooling can improve neurodevelopmental outcome in babies with neonatal encephalopathy.
Methods
234 term infants with moderate to severe neonatal encephalopathy and abnormal amplitude integrated electroenc- ephalography (aEEG) were randomly assigned to either head cooling for 72 h, within 6 h of birth, with rectal temperature maintained at 34-35°C (n=116), or conventional care (n=118). Primary outcome was death or severe disability at 18 months. Analysis was by intention to treat. We examined in two predefined subgroup analyses the effect of hypothermia in babies with the most severe aEEG changes before randomisation—ie, severe loss of background amplitude, and seizures—and those with less severe changes.
Findings
 In 16 babies, follow-up data were not available. Thus in 218 infants (93%), 73/110 (66%) allocated conventional care and 59/108 (55%) assigned head cooling died or had severe disability at 18 months (odds ratio 0·61; 95% CI 0·34-1·09, p=0·1). After adjustment for the severity of aEEG changes with a logistic regression model, the odds ratio for hypothermia treatment was 0·57 (0·32-1·01, p=0·05). No difference was noted in the frequency of clinically important complications. Predefined subgroup analysis suggested that head cooling had no effect in infants with the most severe aEEG changes (n=46, 1·8; 0·49-6·4, p=0·51), but was beneficial in infants with less severe aEEG changes (n= 172, 0·42; 0·22-0·80, p=0·009).
Interpretation
 These data suggest that although induced head cooling is not protective in a mixed population of infants with neonatal encephalopathy, it could safely improve survival without severe neurodevelopmental disability in infants with less severe aEEG changes.
(The Lancet, Volume 365, Number 945729 January 2005)
Comments:
 Need more RCT to find answer whether the intervention indeed has some utility or not. Difficult to maintain sustained hypothermia in routine NICU care and special equipments are needed to selectively cool the head for long period.

Aggressive Early TPN in Low-Birth-Weight Infants. 

Objective. This study aimed to compare nitrogen balance and biochemical tolerance of early aggressive versus late total parenteral nutrition in very-low-birth-weight (VLBW) infants over the first week of life.
Conclusion.
This study shows that aggressive intake of Amino Acids and Intra Lipids can be tolerated immediately after birth by VLBW infants. Also, Early TPN significantly increased positive nitrogen balance and caloric intake, without increasing the risk of metabolic acidosis, hypercholesterolemia, or hypertriglyceridemia.
(Ibrahim HM, Jeroudi MA, Baier RJ, et al.  Journal of Perinatology (August 2004); 24:482-6.)  
 Comments.
 Early aggressive TPN appears to be surprisingly well tolerated in VLBW infants.  I was surprised that despite increased energy intake and improved nitrogen retention, the ETPN group did not gain weight better.

Developmental outcome of the use of etamsylate for prevention of PVH

Objective:
To compare neurodevelopmental outcome of survivors of the multicentre trial of etamsylate (the iRNN for ethamsylate) for prevention of periventricular haemorrhage in very low birthweight infants.
Setting:
 Six neonatal intensive care units in the United Kingdom. Neurodevelopmental outcome was assessed in health premises or children’s homes.
Subjects:
 268 of 276 survivors of the original study were seen between 3.5 and 4.2 years of age. All were inborn and weighed 1500 g or less at birth.
Intervention:
 Etamsylate 12.5 mg/kg or placebo six hourly from within one hour of delivery for four days.
Results:
There was no difference between the groups in neuromotor outcome (cerebral palsy) or in the general cognitive index (GCI) of the McCarthy scales (mean GCI was 93.3 for the etamsylate group (n  =  133) and 89.7for the placebo group (n  =  131); p  =  0.10). There were more children with GCI < 70 (9 v 19; p  =  0.047) or 50 (3 v 11; p  =  0.03) in the placebo group. Fewer children in the etamsylate group had squints (17 v 30; p  =  0.042) or required surgery for patent ductus arteriosus (1 v 8; p  =  0.036).
Conclusions:
 Etamsylate was not associated with a reduction in cerebral palsy. Severe cognitive impairment was reduced, but more children died and the improvement may be because fewer survived with low GCI.
(Archives of Disease in Childhood Fetal and Neonatal Edition 2005;90:F31-F35)

Slow Versus Rapid Feeding Volume Advancement in Preterm Infants. 

Objectives.
To determine whether infants who are fed initially and advanced at 30 mL/kg per day (intervention) take fewer days to get to full feedings than those who are fed initially and advanced at 20 mL/kg per day (control), without increasing their incidence of feeding complications and necrotizing enterocolitis (NEC). We also examined whether these infants regain birth weight earlier, have fewer days of intravenous fluids, and a have shorter hospital stay.
Methods.
 A randomized, controlled, single-center trial was conducted in a Neonatal Intensive Care Unit of a community-based county hospital in Houston, Texas. Infants between 1000 and 2000 g at birth, gestational age weeks, and weight appropriate for gestational age were allocated randomly to feedings of expressed human milk or Enfamil formula starting and advanced at either 30 mL/kg per day or 20 mL/kg per day. Infants remained in the study until discharge or development of stage NEC.
Results.
A total of 155 infants were enrolled: 72 infants in the intervention group and 83 in the control group. Infants in the intervention group achieved full-volume feedings sooner (7 vs 10 days, median), regained birth weight faster (11 vs 13 days, median), and had fewer days of intravenous fluids (6 vs 8 days, median). Three infants in the intervention group and 2 control infants developed NEC for an overall incidence of 3.2% (relative risk: 1.73; 95% confidence interval: 0.30–10.06).
Conclusion.
Among infants between 1000 and 2000 g at birth, starting and advancing feedings at 30 mL/kg per day seems to be a safe practice and results in fewer days to reach full-volume feedings than using 20 mL/kg per day. This intervention also leads to faster weight gain and fewer days of intravenous fluids.
(Caple J, Armemtrout D, Huseby V et al PEDIATRICS Vol. 114 No. 6 December 2004, pp. 1597-1600.)
Comment: 
Currently we usually advance feedings by 20 ml/kg/day, but this demonstration that increments of 30 ml/kg/day has an acceptable safety profile should result in an immediate change in our clinical practice.  Although morbidities other than NEC were not discussed in this article, one might expect to see a decreased need for peripheral and percutaneous central lines and a lower incidence of bloodstream nosocomial infections.  It would not be prudent to generalize the results of this study to infants with birth weight less than 1000 grams given differences in gastrointestinal physiology and cardiovascular stability.
(NeoNotes Journal Club)
 

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