Serum Trace Elements in Children with Well-Controlled and Drug Refractory Epilepsy Compared to Controls: An Observational Study.

Background: Trace elements have been implicated in pathogenesis of epilepsy. Studies till date have shown altered levels of serum trace elements in children with epilepsy. Objective: The objective of the current was to estimate serum levels of trace elements in children with well-controlled and drug refractory epilepsy and compare it with controls. Methodology: In a tertiary care teaching hospital of North India, serum selenium, copper, zinc, and iron were estimated in well-controlled and drug refractory epileptic children aged 2-12 years and compared with age and gender matched controls. Results: A total of 106 children with epilepsy (55 drug refractory and 51 well controlled) and 52 age and gender matched controls were included in the study. Serum selenium and copper were significantly decreased in cases compared to controls. After classifying epilepsy into well-controlled and drug refractory cases, only in the latter the significant difference for serum selenium and copper levels remained compared to controls. Additionally, in the drug refractory cases, serum iron levels were significantly reduced compared to controls. Conclusions: Serum trace elements are altered in children with epilepsy (more so in the drug refractory group) compared to controls. Monitoring of serum trace elements in children with epilepsy should be considered. Up to one-third of epilepsy is drug refractory of which only another third are amenable to surgery. It is worth investigating the therapeutic potential of altered micronutrient status in these patients.

Delayed cord clamping in Rh-alloimmunised infants: a randomised controlled trial.

Despite advancement in medical care, Rh alloimmunisation remains a major cause of neonatal hyperbilirubinaemia, neuro-morbidity, and late-onset anaemia. Delayed cord clamping (DCC), a standard care now-a-days, is yet not performed in Rh-alloimmunised infants due to paucity of evidence. Hence, we randomised these infants of 28- to 41-week gestation to delayed cord clamping (N = 36) or early cord clamping (N = 34) groups. The primary outcome variable was venous packed cell volume (PCV) at 2 h of birth. The secondary outcomes were incidence of double volume exchange transfusion (DVET) and partial exchange transfusion (PET), duration of phototherapy (PT), functional echocardiography (parameters measured: superior vena cava flow, M-mode fractional shortening, left ventricular output, myocardial perfusion index, and inferior vena cava collapsibility) during hospital stay, and blood transfusion (BT) until 14 weeks of life. Neonates were managed as per unit protocol. The baseline characteristics of enrolled infants were comparable between the groups. The median (IQR) gestation and mean (SD) birth weight of enrolled infants were 35 (33-37) weeks and 2440 (542) g, respectively. The DCC group had a higher mean PCV at 2 h of life (48.4 ± 9.2 vs. 43.5 ± 8.7, mean difference 4.9% (95% CI 0.6-9.1), p = 0.03). However, incidence of DVET and PET, duration of PT, echocardiography parameters, and BT until 14 weeks of postnatal age were similar between the groups.Conclusion: DCC in Rh-alloimmunised infants improved PCV at 2 h of age without significant adverse effects.Trial registration: Clinical Trial Registry of India (CTRI), Ref/2016/11/012572 http://ctri.nic.in/Clinicaltrials, date of trial registration 19.12.2016, date of first patient enrolment 1 January 2017.What is Known:•Delayed cord clamping improves haematocrit, results in better haemodynamic stability, and decreases the need of transfusion in early infancy.•However, due to lack of evidence, potential risk of hyperbilirubinaemia, and exacerbation of anaemia (following delayed cord clamping), early cord clamping is the usual norm in Rh-alloimmunised infantsinfants.What is New:•Delayed cord clamping in Rh-alloimmunised infants improves haematocrit at 2 h of life without any increase in incidence of serious adverse effects.

Complementary feeding at 4 versus 6 months of age for preterm infants born at less than 34 weeks of gestation: a randomised, open-label, multicentre trial.

BACKGROUND: Evidence on the optimal time to initiation of complementary feeding in preterm infants is scarce. We examined the effect of initiation of complementary feeding at 4 months versus 6 months of corrected age on weight for age at 12 months corrected age in preterm infants less than 34 weeks of gestation. METHODS: In this open-label, randomised trial, we enrolled infants born at less than 34 weeks of gestation with no major malformation from three public health facilities in India. Eligible infants were tracked from birth and randomly assigned (1:1) at 4 months corrected age to receive complementary feeding at 4 months corrected age (4 month group), or continuation of milk feeding and initiation of complementary feeding at 6 months corrected age (6 month group), using computer generated randomisation schedule of variable block size, stratified by gestation (30 weeks or less, and 31-33 weeks). Iron supplementation was provided as standard. Participants and the implementation team could not be masked to group assignment, but outcome assessors were masked. Primary outcome was weight for age Z-score at 12 months corrected age (WAZ12) based on WHO Multicentre Growth Reference Study growth standards. Analyses were by intention to treat. The trial is registered with Clinical Trials Registry of India, number CTRI/2012/11/003149. FINDINGS: Between March 20, 2013, and April 24, 2015, 403 infants were randomly assigned: 206 to receive complementary feeding from 4 months and 197 to receive complementary feeding from 6 months. 22 infants in the 4 month group (four deaths, two withdrawals, 16 lost to follow-up) and eight infants in the 6 month group (two deaths, six lost to follow-up) were excluded from analysis of primary outcome. There was no difference in WAZ12 between two groups: -1·6 (SD 1·2) in the 4 month group versus -1·6 (SD 1·3) in the 6 month group (mean difference 0·005, 95% CI -0·24 to 0·25; p=0·965). There were more hospital admissions in the 4 month group compared with the 6 month group: 2·5 episodes per 100 infant-months in the 4 month group versus 1·4 episodes per 100 infant-months in the 6 month group (incidence rate ratio 1·8, 95% CI 1·0-3·1, p=0·03). 34 (18%) of 188 infants in the 4 month group required hospital admission, compared with 18 (9%) of 192 infants in the 6 month group. INTERPRETATION: Although there was no evidence of effect for the primary endpoint of WAZ12, the higher rate of hospital admission in the 4 month group suggests a recommendation to initiate complementary feeding at 6 months over 4 months of corrected age in infants less than 34 weeks of gestation. FUNDING: Indian Council of Medical Research supported the study until Nov 14, 2015. Subsequently, Shuchita Gupta's salary was supported for 2 months by an institute fellowship from All India Institute Of Medical Sciences, and a grant by Wellcome Trust thereafter.

Iron Stores in Term and Late Preterm Small for Gestational Age and Appropriate for Gestational Age Neonates at Birth and in Early Infancy.

OBJECTIVE: To compare body iron stores in late preterm and term small for gestational age (SGA) infants with gestation matched appropriate-for-gestational age (AGA) infants at birth and at 2 mo of age. METHODS: In this prospective observational study, live births of 34-42 wk gestation and SGA (<10th centile for GA) were enrolled along with gestation matched AGA (10th-90th centile for GA) infants. Infants' blood samples were taken within 2 h of delivery, and repeated at 60 ± 7 d of life. Primary outcome was serum ferritin at birth and 60 d of age. Secondary outcomes were hematocrit at birth and 60 d and need for transfusion until 60 d of life. RESULTS: A total of 37 SGA (gestation 37.2 ± 1.9 wk, birth weight 1861 ± 401 g) and 30 AGA infants (gestation 37.3 ± 1.9 wk, birth weight 2607 ± 405 g) were enrolled in the study. There was no difference in the serum ferritin between AGA and SGA infants at birth {median [IQR]: 254.0 [214.3-293.8] vs. 259.7 [217.8-301.5] µg/L; p = 0.85} or 60 d of life {147.2 [101.4-193.0] vs. 155.0 [106.6-203.6] µg/L; p = 0.81}. Mean hematocrit was 55.5 ± 9.6 vs. 52.4 ± 5.0 at birth (p = 0.10) and 32.1 ± 4.9 vs. 31.6 ± 3.8 at 60 d (p = 0.77) in SGA and AGA infants respectively. No infant required blood transfusion during the study period. CONCLUSIONS: Iron stores of late preterm and term SGA infants are comparable to term AGA infants at birth and 2 mo of age. Recommendations on iron supplementation to these infants need to be formulated through appropriately designed randomized trials.

Trial of daily vitamin D supplementation in preterm infants.

OBJECTIVE: To compare the effect of 800 vs 400 IU of daily oral vitamin D3 on the prevalence of vitamin D deficiency (VDD) at 40 weeks' postmenstrual age (PMA) in preterm infants of 28 to 34 weeks' gestation. METHODS: In this randomized double-blind trial, we allocated eligible infants to receive either 800 or 400 IU of vitamin D3 per day (n = 48 in both groups). Primary outcome was VDD (serum 25-hydroxyvitamin D levels <20 ng/mL) at 40 weeks' PMA. Secondary outcomes were VDD, bone mineral content, and bone mineral density at 3 months' corrected age (CA). RESULTS: Prevalence of VDD in the 800-IU group was significantly lower than in the 400-IU group at 40 weeks (38.1% vs. 66.7%; relative risk: 0.57; 95% confidence interval: 0.37-0.88) and at 3 months' CA (12.5% vs. 35%; relative risk: 0.36; 95% confidence interval: 0.14-0.90). One infant (2.4%) in the 800-IU group had vitamin D excess (100-150 ng/mL). Bone mineral content (mean ± SD: 79.6 ± 16.8 vs. 84.7 ± 20.7 g; P = .27) and bone mineral density (0.152 ± 0.019 vs. 0.158 ± 0.021 g/cm2; P = .26) were not different between the 2 groups. CONCLUSIONS: Daily supplementation with 800 IU of vitamin D reduces the prevalence of VDD at 40 weeks' PMA and at 3 months' CA in preterm infants without showing any improvement in bone mineralization. However, there is a possibility that this dose may occasionally result in vitamin D excess.

Phenobarbitone in Rh hemolytic disease of the newborn: a randomized double-blinded placebo-controlled trial.

OBJECTIVE: To evaluate the efficacy of prophylactic oral phenobarbitone (PB) in neonates with Rh hemolytic disease of the newborn. STUDY DESIGN: In this double-blind randomized trial conducted in a tertiary care unit, we randomly allocated neonates with Rh hemolytic disease of the newborn born at or after 32 weeks' gestation to PB (10 mg/kg/day on day 1 followed by 5 mg/kg/day on days 2-5) (n = 23) or oral glucose (n = 21). The primary outcome was the duration of phototherapy. RESULTS: Baseline variables were comparable. There was no difference in the median duration of phototherapy [54 (range: 0-180) vs. 35 h (0-127); p = 0.39] and in the incidences of failure of phototherapy or significant rebounds of serum bilirubin. However, the proportion of infants with cholestasis was significantly lower in the PB group (0 vs. 19%; p = 0.04). CONCLUSIONS: PB does not reduce duration of phototherapy or its episodes. Its potential to reduce cholestasis needs validation in larger studies.

Poor zinc status in early infancy among both low and normal birth weight infants and their mothers in Delhi.

BACKGROUND: Low birth weight (LBW) infants are at high risk of zinc deficiency, but there is a paucity of data on their zinc status. OBJECTIVE: To evaluate zinc status of LBW (BW <2,500 g) and normal birth weight (NBW; BW ≥ 2,500 g) infants at birth and in early infancy. METHODS: A total of 339 infants (LBW, n = 220; NBW, n = 119) were enrolled, and venous blood samples of mother-infant dyad were taken within 48 h of birth. Infants' levels were repeated between 2 and 10 months of age. Serum zinc levels were estimated using an inductively coupled plasma mass spectrometer. Primary outcome was zinc deficiency, defined as serum zinc <65 µg/dl. RESULTS: Zinc results were available for 182 LBW and 103 NBW infants at birth and for 100 LBW and 66 NBW infants at follow-up with a median postnatal age of 14 and 15.5 weeks, respectively. Median zinc levels were low and comparable at birth as well as at follow-up, with zinc deficiency being present in 51.0% of LBW and 42.4% of NBW infants at birth and in 79.0% of LBW and 66.7% of NBW infants at follow-up. Zinc levels decreased significantly in both groups from birth to follow-up, irrespective of zinc multivitamin supplementation. Zinc levels of infants with BW <2,000 g at follow-up were significantly lower compared to infants with higher BW. CONCLUSION: Zinc status was poor in many infants at birth irrespective of BW. Zinc status worsened significantly during early infancy, with infants with BW <2,000 g having the lowest zinc levels.

Vitamin D status of low birth weight infants in Delhi: a comparative study.

OBJECTIVE: To evaluate vitamin D status of preterm and term low birthweight (LBW) and term normal birth weight (NBW; weight ≥ 2500 g) infants at birth and in early infancy. METHODS: We enrolled 220 LBW and 119 NBW infants along with their mothers. Blood samples of both infants and mothers were taken within 48 h of birth, and that of infants were repeated at 3 months. Serum levels of calcium, phosphate, alkaline phosphatase, 25 hydroxyvitamin D (25OHD) and parathormone (PTH) were estimated using standard tests. Our primary outcome was vitamin D deficiency (VDD; serum 25OHD <20 ng/ml in mothers and <15 ng/ml in infants). Other outcomes were raised PTH (>46 pg/ml), raised AlkP (>120 U/l in mothers and 420 U/l in infants), and clinical rickets. FINDINGS: VDD was present in 186 (87.3%) of LBW and 103 (88.6%) of NBW infants at birth, and in 77 (60.6%) of LBW and 55 (71.6%) of NBW infants at a median corrected age of 12 and 15 weeks, respectively. VDD was almost universal (93-97%) among mothers of both groups. Raised PTH was present in 138 (63.6%) of LBW and 48 (41.4%) of NBW infants at birth, and in 58 (45.7%) of LBW and 38 (49.3%) of NBW infants at follow-up. Clinical rickets was present in 17 (13.4%) of LBW and 4 (4.9%) of NBW infants at 12-14 weeks of corrected age. CONCLUSIONS: High prevalence of VDD in LBW as well as NBW infants with clinical rickets at an early age underlines the need to study the effect of various vitamin D supplementation regimens in these infants to identify the optimal dose.

Evaluation of phototherapy devices used for neonatal hyperbilirubinemia.

OBJECTIVE: To compare phototherapy devices based on their physical and photo-biological characteristics viz spectral properties, maximum and mean irradiance, treatable percentage of body surface area, decay of irradiance over time and in vitro photoisomerisation of bilirubin. DESIGN: In vitro experimental study. SETTING: Ocular pharmacy laboratory at a tertiary care hospital. METHODLOGY: All the characteristics were measured at a fixed distance of 35 cm from one compact fluorescent lamp (CFL) and three light emitting diode (LED) phototherapy devices in a dark room with an irradiance of <0.1uW/cm2/nm. Estimation of products of in vitro photoisomerisation was done using liquid chromatography - tandem mass spectroscopy (LC-MS/MS). RESULTS: The emission spectral data were comparable between the phototherapy devices. The devices, however, differed in their maximum irradiance with the spot and indigenous LED units having the highest and lowest values, respectively (56.5 and 16.8uW/cm2/nm). The mean irradiance measured in 5x5cm grids falling within the silhouette of a term baby of the spot and improvised LED devices were low (26.8uW/cm2/nm and 11.5uW/cm2/nm, respectively) possibly due to unevenness in the irradiance of light falling within the silhouette. There was a significant difference in the amount of bilirubin left after exposure to light over a 2hour time period (% reduction of bilirubin) among the four devices (P=0.001); at 120 minutes after exposure, the amount of bilirubin left was lowest for the CFL (16%) and spot LED (17%) devices and highest for the indigenous LED unit (41%). CONCLUSIONS: The four phototherapy devices differed markedly in their physical and photobiological characteristics. Since the efficacy of a device is dependent not only on the maximum irradiance but also on the mean irradiance, rate of decay of irradiance, and treatable surface area of the foot print of light, each phototherapy device should have these parameters verified and confirmed before being launched for widespread use.

Hypocalcemia in the newborn.

Hypocalcemia is a frequently observed clinical and laboratory abnormality in neonates. Ionic calcium is crucial for many biochemical processes including blood coagulation, neuromuscular excitability, cell membrane integrity, and many of the cellular enzymatic activities. Healthy term infants undergo a physiological nadir in serum calcium levels by 24-48 h of age. This nadir may drop to hypocalcemic levels in high-risk neonates including infants of diabetic mothers, preterm infants and infants with perinatal asphyxia. The early onset hypocalcemia which presents within 72 h requires treatment with calcium supplementation for at least 72 h. In contrast, late onset hypocalcemia usually presents after 7 days and requires longer term therapy.

Early iron supplementation in very low birth weight infants--a randomized controlled trial.

AIM: To evaluate if supplementing iron at 2 weeks of age improves serum ferritin and/or haematological parameters at 2 months of life in very low birth weight (VLBW) infants. METHODS: Preterm VLBW infants who received at least 100 mL/kg/day of oral feeds by day 14 of life were randomized to either 'early iron' (3-4 mg/kg/day orally from 2 weeks) or 'control' (no iron until 60 days) groups. Infants were followed up fortnightly and all morbidities were prospectively recorded. Serum ferritin was measured at 60 days by enzyme immunoassay method. RESULTS: Forty-six infants were included in the study; primary outcome was available for 42 infants.There was no difference in either serum ferritin (mean: 50.8 vs. 45.3 microg/L; adjusted difference in means: 5.8, 95% CI: -3.0, 14.6; p = 0.19) or haematocrit (32.5 +/- 5.3 vs. 30.8 +/- 6.3%; p = 0.35)at 60 days between the early iron and control groups. The magnitude of fall in serum ferritin from baseline to the end of study period was also not different between the groups (4.9 vs. 13.8 microg/L; difference in means: 8.8; 95% CI: -0.3, 17.9; p = 0.06). The requirement of blood transfusions (9.5 vs. 13%; p = 0.63) and a composite outcome of common neonatal morbidities (19% vs. 21.7%; p = 0.55) were also not different between the two groups. CONCLUSION: Supplementing iron at 2 weeks of age in preterm VLBW infants did not improve either serum ferritin or the haematological parameters at 2 months when compared to the standard practice of starting iron from 8 weeks of age.

Alma-Ata 30 years on: revolutionary, relevant, and time to revitalise.

In this paper, we revisit the revolutionary principles-equity, social justice, and health for all; community participation; health promotion; appropriate use of resources; and intersectoral action-raised by the 1978 Alma-Ata Declaration, a historic event for health and primary health care. Old health challenges remain and new priorities have emerged (eg, HIV/AIDS, chronic diseases, and mental health), ensuring that the tenets of Alma-Ata remain relevant. We examine 30 years of changes in global policy to identify the lessons learned that are of relevance today, particularly for accelerated scale-up of primary health-care services necessary to achieve the Millennium Development Goals, the modern iteration of the "health for all" goals. Health has moved from under-investment, to single disease focus, and now to increased funding and multiple new initiatives. For primary health care, the debate of the past two decades focused on selective (or vertical) versus comprehensive (horizontal) delivery, but is now shifting towards combining the strengths of both approaches in health systems. Debates of community versus facility-based health care are starting to shift towards building integrated health systems. Achievement of high and equitable coverage of integrated primary health-care services requires consistent political and financial commitment, incremental implementation based on local epidemiology, use of data to direct priorities and assess progress, especially at district level, and effective linkages with communities and non-health sectors. Community participation and intersectoral engagement seem to be the weakest strands in primary health care. Burgeoning task lists for primary health-care workers require long-term human resource planning and better training and supportive supervision. Essential drugs policies have made an important contribution to primary health care, but other appropriate technology lags behind. Revitalisng Alma-Ata and learning from three decades of experience is crucial to reach the ambitious goal of health for all in all countries, both rich and poor.

Parenteral nutrition.

Nutritional insufficiency, leading to early growth deficits has long-lasting effects, including short stature and poor neurodevelopmental outcomes. Early enteral feeding is commonly limited by immaturity of gastrointestinal motor function in preterm neonates. To ensure that a stressed premature infant receives an adequate but not excessive amount of glucose, the amount of carbohydrate delivered in the form of dextrose is commonly initiated at the endogenous hepatic glucose production and utilization rate of 4 to 6 mg/kg/min; and 8 to 10 mg/kg/min in ELBW infants. The early provision of protein is critical to attain positive nitrogen balance and accretion as premature babies lose approximately 1% of their protein stores daily. Aminoacid can be used at concentrations of 3-3.5 g/kg/day and lipid at 3.5-4 g/kg/day as long as the fat intake remains less than 60% of nonprotein calories. Sodium, potassium, chloride, calcium, magnesium and phosphorus need to be provided in PN solution as per their daily needs. Hospital-acquired infection (HAI) is a major complication of PN. All efforts should be made to avoid it.

Jaundice in the newborns.

Hyperbilirubinemia is the commonest morbidity in the neonatal period and 5-10% of all newborns require intervention for pathological jaundice. Neonates on exclusive breast-feeding have a different pattern and degree of jaundice as compared to artificially fed babies. Latest guidelines from the American Academy of Pediatrics (AAP) for management of jaundice in a normal term newborn have been included in the protocol. Separate guidelines have been provided for the management of jaundice in sick term babies, preterm and low birth weight babies, for hemolytic jaundice and prolonged hyperbilirubinemia.

Hypocalcemia in the newborn.

Healthy term babies undergo a physiological nadir in serum calcium levels by 24-48 hours of age. The nadir may be related to the delayed response of parathyroid and calcitonin hormones in a newborn. This nadir may drop to hypocalcemic levels in high-risk neonates including infants of diabetic mothers, preterm infants and infants with perinatal asphyxia. The early onset hypocalcemia which presents within 72 hours, requires treatment with calcium supplementation for at least 72 hours. In contrast, late onset hypocalcemia usually presents after 7 days and requires long term therapy. Ionized calcium is crucial for many biochemical processes and total serum calcium is a poor substitute for the diagnosis of hypocalcemia.

Breastfeeding practices and health-seeking behavior for neonatal sickness in a rural community.

The aim of the study was to evaluate the knowledge of mothers and grandmothers regarding breastfeeding and health-seeking behavior for neonatal sickness in a rural community. A cross-sectional survey, using a triangulation of qualitative (focus group discussion) and quantitative (structured questionnaire) methods was carried out. Although most of the grandmothers and mothers believed in early feeding within 2 h of delivery, they often administered prelacteal feeds such as ghutti and honey. Colostrum was considered beneficial. Most respondents believed that ghutti, water, or both should be given along with breastmilk. Diluted buffalo milk was the preferred choice if supplementation was required. It was thought that weaning should be introduced after 6 months of life. Mothers preferred to give dalia and khichri as the initial weaning food compared to roti and dal water by grandmothers. Both grandmothers and mothers felt that a baby who was playful and not crying excessively was usually healthy. Most of the respondents described the normal pattern of breathing, feeding, urination, and defecation adequately. Most of the grandmothers and mother's felt that by touching forehead and limbs of baby could reliably assess temperature. Refusal to feed was considered as a marker of a sickness by most grandmothers and mothers. However, they also believed that health-seeking for poor feeding could be delayed for 1 day. Respiratory distress was described by the presence of fast respiration, chest retractions, or noisy breathing. Most respondents did not know how to assess cyanosis or seizures. Jaundice was descried as yellowish discoloration of skin, eyes, and urine. Failure to pass urine for 4-6 h bothered most of the respondents. The first response to illness was home remedies. The choice of healthcare was unqualified village practitioners followed by government hospital. Knowledge regarding desirable breastfeeding practices was inadequate and quite a few inappropriate beliefs were widely prevalent. Although knowledge regarding sickness was present, health-seeking from qualified providers was considerably delayed with most respondents preferring village practitioners to government hospitals.

Efficacy of oral phenobarbitone in term "at risk" neonates in decreasing neonatal hyperbilirubinemia: a randomized double-blinded, placebo controlled trial.

OBJECTIVE: To evaluate the efficacy of oral phenobarbitone in "at risk " term neonates (with high cord bilirubin) in decreasing hyperbilirubinemia. DESIGN: Double blind, placebo-control, randomized trial. SETTING: Tertiary level neonatal unit. OUTCOME: Primary-hyperbilirubinemia defined as total serum bilirubin (TSB) greater than 13 mg/dL. Secondary-TSB at 72 +/- 12 hr, need for phototherapy or exchange transfusion and side effects of phenobarbitone therapy. METHODS: All consecutively born term healthy neonates with cord bilirubin > or = 2.5 mg/dL were randomly assigned to receive either phenobarbitone (n = 37) or placebo (n = 38) after obtaining informed consent. Phenobarbitone was administered orally (5 mg/kg/day) for 3 days starting within 12 hours of birth. The neonates were followed up till seven days of life. TSB was estimated in neonates who developed jaundice with clinically assessed level of 8-10 mg/dL and at 72 +/-12 hours of age in 55 neonates. RESULTS: The baseline characteristics were similar in two groups. There was no significant reduction in incidence of hyperbilirubinemia in phenobarbitone group compared to in placebo group (6/37 (16.2%) versus 13/38 (34.3%); RR 0.47, 95% confidence interval: 0.20-1.11; risk difference: -18.1%, 95% confidence interval: -39.5 to 3.3%). However TSB at 72 +/-12 hours in phenobarbitone group (mean +/- S.D: 10.0 +/- 3.7 mg/dL) was significantly lesser than in placebo group (mean +/- S.D: 12.3 +/- 3.3 mg/dL) (difference of means: -2.3 mg/dL, 95% confidence interval: -3.9 to -0.7 mg/dl, P = 0.018). No significant difference with respect to need for treatment was observed in two groups. No significant adverse effects of phenobarbitone were noted. CONCLUSIONS: Prophylactic phenobarbitone is not helpful in reducing the incidence of hyper-bilirubinemia in "at risk" term neonates.

Effect of fortification with human milk fortifier (HMF) and other fortifying agents on the osmolality of preterm breast milk.

This study was conducted to test the effect of fortification with human milk fortifier (HMF), low birth weight (LBW) formula and coconut oil, initially and upon subsequent storage, on the osmolality of preterm breast milk. Milk samples (n = 48) were collected from mothers (n = 25) delivered at 34 pounds weeks and fortified with HMF (Lactodex-HMF), LBW formula (Lactodex-LBW) and edible coconut oil. Osmolality was measured before and after fortification and after 6 hours,.The gestation and birth weight (median) was 31 (range 29-32) weeks and 1198 (range 716-1478) grams. The median (range) postnatal age at testing was 15 days (range 3-60 days). There was a significant increase in osmolality of breast milk (302.3 +/- l.82) after addition of HMF (392.9 +/- 3.01) and LBW formula (390.5 +/- 2.4). There was no change in osmolality with addition of coconut oil (304 +/- 1.6). There was no further change in the osmolality after 6 hours of storage at 4 degrees C.