The impact of DocosaHexaenoic Acid supplementation during pregnancy and lactation on Neurodevelopment of the offspring in India (DHANI): trial protocol.

BACKGROUND: Evidence suggests a strong association between nutrition during the first 1000 days (conception to 2 years of life) and cognitive development. Maternal docosahexaenoic acid (DHA) supplementation has been suggested to be linked with cognitive development of their offspring. DHA is a structural component of human brain and retina, and can be derived from marine algae, fatty fish and marine oils. Since Indian diets are largely devoid of such products, plasma DHA levels are low. We are testing the effect of pre- and post-natal DHA maternal supplementation in India on infant motor and mental development, anthropometry and morbidity patterns. METHODS: DHANI is a double-blinded, parallel group, randomized, placebo controlled trial supplementing 957 pregnant women aged 18-35 years from ≤20 weeks gestation through 6 months postpartum with 400 mg/d algal-derived DHA or placebo. Data on the participant's socio-demographic profile, anthropometric measurements and dietary intake are being recorded at baseline. The mother-infant dyads are followed through age 12 months. The primary outcome variable is infant motor and mental development quotient at 12 months of age evaluated by Development Assessment Scale in Indian Infants (DASII). Secondary outcomes are gestational age, APGAR scores, and infant anthropometry. Biochemical indices (blood and breast-milk) from mother-child dyads are being collected to estimate changes in DHA levels in response to supplementation. All analyses will follow the intent-to-treat principle. Two-sample t test will be used to test unadjusted difference in mean DASII score between placebo and DHA group. Adjusted analyses will be performed using multiple linear regression. DISCUSSION: Implications for maternal and child health and nutrition in India: DHANI is the first large pre- and post-natal maternal dietary supplementation trial in India. If the trial finds substantial benefit, it can serve as a learning to scale up the DHA intervention in the country. TRIAL REGISTRATION: The trial is retrospectively registered at clinicaltrials.gov ( NCT01580345 , NCT03072277 ) and ctri.nic.in ( CTRI/2013/04/003540 , CTRI/2017/08/009296 ).

Docosahexaenoic Acid Supplementation in Lactating Women Increases Breast Milk and Erythrocyte Membrane Docosahexaenoic Acid Concentrations and Alters Infant n-6:n-3 Fatty Acid Ratio.

Background: Low concentrations of docosahexaenoic acid (DHA) or high n-6 (ω-6):n-3 ratio in pregnant women is associated with poor fetal growth velocity and suboptimal neurodevelopment. However, there is a lack of data on levels of important n-6 and n-3 fatty acids (FAs) at different time points during pregnancy and lactation from India. Data on how much DHA is transferred during actual supplementation are also scarce. Objectives: We report the concentrations of n-6 and n-3 FAs in maternal and infant blood and in breast milk following maternal supplementation with DHA or placebo. Methods: A total of 957 pregnant women (≤20 wk) from Belagavi, Karnataka, were randomly assigned to receive either 400 mg/d of algal DHA or placebo through 6 mo postpartum. Blood samples were collected from the mother at recruitment/baseline, delivery, and 6 mo postpartum and from the infant at birth (cord) and 12 mo (venous). Breast milk samples were collected from a subsample at delivery, 1 mo and 6 mo postpartum. The FA profile was analyzed using gas chromatography. Results: The concentration of DHA appeared to be higher in erythrocyte and breast milk samples of the DHA-supplemented group at all subsequent time points. The n-6:n-3 ratio was lower among women in the DHA group at delivery [DHA: 4.08 (1.79); placebo: 5.84 (3.57); P < 0.001] and at 6 mo postpartum [DHA: 5.34 (2.64); placebo: 7.69 (2.9); P < 0.001]. Infants of DHA-supplemented mothers also had a lower n-6:n-3 ratio at delivery and 12 mo. The n-6:n-3 ratio of breast milk increased from delivery through 1 to 6 mo but remained lower in the DHA-supplemented group than in the placebo. Conclusions: Maternal DHA supplementation with 400 mg/d from early pregnancy through 6 mo postpartum significantly increased circulating DHA in breast milk and infant erythrocyte, whereas decreased erythrocyte and breast milk n-6:n-3 ratio. However, maternal supplementation did not get the ratio to the recommended levels.

Results of the Max Page muscle sliding operation for the treatment of Volkmann's ischemic contracture of the forearm.

BACKGROUND: Volkmann's ischemic contracture is a less common but crippling condition affecting the extremities. Once the condition sets in, the prognosis always remains guarded, even after long and intensive physiotherapy and various restorative surgical techniques. This study was undertaken to evaluate the long-term functional results of the Max Page muscle slide operation in patients with Volkmann's ischemic contracture of the forearm of moderate degree (Tsuge classification). MATERIALS AND METHODS: Nineteen patients treated between 1997 and 2009 were evaluated. The functional outcome (measured as the dexterity score, hand grip strength, sensibility, and appearance) was analyzed postoperatively. The pre- and postoperative values were compared using a paired t test. The final results were graded as good, fair, and poor. RESULTS: The average age at the time of presentation was 18 years (range 3-25 years). Tight external splintage for injuries around elbow and forearm was the primary factor. The mean period of follow-up was 3.53 years. Fifteen patients were able to achieve good functional results. Three had fair and one had poor results. All three variables showed significant improvements postoperatively. Wound dehiscence was the most common complication. One patient needed a second surgery to restore good hand function. CONCLUSION: The Max Page muscle sliding operation to treat Volkmann's ischemic contracture of moderate degree gives good functional results. The procedure is simple and easy to perform. Adequate muscle release and proper postoperative physiotherapy are key to achieving good results.

Antepartum Risk Assessment for Pregnant Women Visiting a Tertiary Care University Teaching Hospital in Southern India.

AIM: The study was conducted to assess the prevalence of high-risk pregnancy (HRP) cases among pregnant women visiting the Prabhakar Kore Hospital (PKH) at Belagavi, Karnataka for antenatal care (ANC) and determination of the level of risk in the identified cases. MATERIALS & METHODS: Data were collected as a part of a screening procedure of a nutrition supplement clinical trial on pregnant women [Study title: Maternal DHA Supplementation and offspring Neurodevelopment in India (DHANI)]. ANC case records including detailed notes on medical and obstetric history, physical examination, laboratory investigations of pregnant women with ≤ 20 weeks of gestational age were screened for known risk factors. RESULTS: A total of 11,686 new cases were registered for ANC between June 2016 through August 2017. Of these, 3379 (<20 weeks gestation) were screened out of 428 pregnant women, 12.6% pregnant women were found to be at risk, 40.2% (n=172) fell in the high-risk category. Most commonly reported risk factors were thyroid disorders (27.3%, hypothyroidism 17.3%; hyperthyroidism 10%), gestational diabetes (16.1%), bad obstetric history (12.6%) and anaemia (10.7%). CONCLUSION: Early identification of these at-risk mothers through a simple, practical, reliable and customized risk scoring schedule can ensure interventions either to control the risk causing factor or delivery of timely and appropriate care as and when needed. CLINICAL SIGNIFICANCE: Considering the disproportionate burden that high risk pregnancies pose on higher mortality rates and compromised quality of life for the cases which survive, early identification of these high risk cases (12.6% identified in this study) can have a significant impact on maternal and child health. The population negatively affected by at-risk pregnancies is only expected to increase in the near future in light of the rising trend of its known risk factors such as high blood pressure, diabetes, or being HIV-positive.

Zancolli lasso procedure for correction of paralytic claw hands.

PURPOSE: To evaluate the outcome of 20 claw hands corrected with the Zancolli lasso procedure. METHODS: 20 patients aged 7 to 48 (mean, 28) years with claw hand deformity for a mean of 33.3 months secondary to leprosy (n=17), traumatic ulnar nerve injury (n=2), or tardy ulnar nerve palsy (n=1) underwent the Zancolli lasso procedure, in which the flexor digitorum superficialis (FDS) of the middle finger was divided in to 4 slips (one for each finger) and reattached to itself after passing through the proximal pulley. Deformity, power, movement, and function of the hands were evaluated before and after surgery. RESULTS: The mean duration of surgery was 58.4 (range, 50-107) minutes. The mean duration of follow-up was 18 (range, 12-24) months. Deformity correction was good in 15 patients, fair in 3, and poor in 2. The mean angle improvement was maximum in the little finger, followed by the ring, index, and middle fingers. The transverse metacarpal arch (compared with the normal hand) was increased/reversed in 7 patients and decreased in 13 patients. The grip and pinch strength increased in 13 patients, remained unchanged in 6, and decreased in one. Motion and function of the hand was good in 12 patients, fair in 6, and poor in 2. One patient developed swan neck deformity in the little finger owing to suture tension of the transferred slip, and another had paraesthesia over the index finger. They underwent reoperation using the FDS of the ring finger; no sensory or motor recovery was achieved. CONCLUSION: The Zancolli lasso procedure is easy to perform and does not require extensive postoperative training. It restores synchronous finger flexion and spares other superficialis tendons, thus avoiding swan neck deformity of the fingers.

Sensory recovery in the plantar aspect of the foot after surgical decompression of posterior tibial nerve. Possible role of steroids along with decompression.

In leprosy, involvement of the posterior tibial nerve leads to sensory loss in the plantar aspect of the foot. As a result plantar ulcers are common and lead to deformity and disability. Restoration of plantar sensation can prevent ulcer formation. Posterior tibial decompression was done for the recovery of sensation in the plantar aspect of the foot. Seventy-two patients under went decompression on 84 feet, 25 received steroids pre- and post-operatively. The recovery of sensation was better if surgery was done before 6 months of onset of anaesthesia. Decompression along with steroids gave better results than decompression alone in patients with active neuritis especially in BT cases whereas in BB, BL and LL cases there was no significant improvement of sensation. The results are discussed.

Collagen sheet and its usefulness in healing of ulcers in leprosy patients.

Collagen is a natural tissue present in the body. For healing of any part collagen is essential. Collagen has been made available in the form of sheets for clinical use, by the Central Leather Research Institute, Adyar, Madras 20. It has been tried in burns and ulcers. Plantar ulcers are common in leprosy and pose a problem in healing. Therefore, collagen was tried in our Institute on 75 patients having plantar ulcers, other type of ulcers like stasis ulcers and post operative wounds. It has been found from our study that Collagen Sheet hastens the healing of wounds.

Restoration of plantar sweat secretion in the feet of leprosy patients.

As part of the studies on nerve damage and its consequences in leprosy, the status of sweat gland function in the anaesthetic sole of the feet of leprosy patients was investigated qualitatively and semi-quantitatively, before and after surgical decompression of the posterior tibial neurovascular bundle. Sweat prints of the feet of the patients were obtained pre-operatively and postoperatively on Whatman's No. 1 filter paper. The paper was treated with one percent Ninhydrin and the intensities of the Ninhydrin positive areas were quantitated. Forty one feet of thirty six patients have been studied in this manner. Sweat print analysis of twenty normal people have also been done, and included for comparison. This operative procedure has been found to effect an improvement in the sweat gland function in the feet of more than fifty percent of leprosy patients studied so far.

Results of non-vascularised fibular grafting in gap non-union of long bones in paediatric age group.

BACKGROUND: Bone defect has always been a challenge to treat for the orthopaedic surgeon. Fibular grafting is a popular method for bridging the gap in bone defects created by tumour excision, trauma or bone loss as sequelae to infection. Fibula is a popular substitute for this method because of its easy accessibility and minimal donor site morbidity. The present study is aimed at finding the results in paediatric population. MATERIAL AND METHODS: 20 patients with bone defect (19 as a result of chronic osteomyelitis and one as a result of excision of a tumour) were included in the current study. The age of the patients ranged from one year to 12 years. The fibular graft was applied after freshening of bone end and fixed with K wire or plating and cancellous bone graft was also applied at both ends. The limb was immobilized in plaster till union of fibula at both ends. RESULTS: The average gap was 8 cm (range 6-12 cm). Out of the twenty cases nine involved the humerus, seven in the tibia, two in radius and one each in femur and ulna. Union was achieved at both ends in 80% of the patients after the first surgery. Three out of six patients with K wire as fixation device failed and one out of fourteen patients with plate as fixation device ended in non-union. Union was achieved in these patients after revision surgery. One patient had stress fracture at distal end of the plate after weight bearing. Union occurred in this patient after plaster immobilization. Range of motion at distal and proximal joint was comparable to normal side. Superficial infection was seen in two patients and they responded to antibiotics. CONCLUSION: Non-vascularised fibular grafting is a good option for bone defects in paediatric population provide adequate fixation and immobilization has been done. LEVEL OF EVIDENCE: Level IV (Therapeutic).

Development and Evaluation of Patient Information Leaflets (PIL) Usefulness.

A prospective study was conducted to develop, validate and assess the usefulness of the patient information leaflets for selected diseases among the patient population. Flesch readability ease score, Baker Able leaflet design criteria were applied to develop the patient information leaflets. The leaflets were validated for both content and translation. Eligible patients meeting the study criteria were enrolled in the study. Suitably designed knowledge, attitude and practice questionnaire was administered at base line followed by patient education complimented with an information leaflet. After a month, knowledge, attitude and practice questionnaire was administered once again to assess the influence of education and usefulness of patient information leaflets on knowledge, attitude and practice scores. The mean readability score of the information leaflets is 80 and Baker Able leaflet design criteria score is 22. Post education knowledge, attitude and practice scores were significantly (P<0.0001) improved in all the enrolled patients in all disease. The study concludes that patient education complemented with suitably designed information leaflet has greater impact on knowledge, attitude and practice of the patients towards their disease management.

Maternal and perinatal outcome during expectant management of severe pre-eclampsia between 24 and 34 weeks of gestation.

OBJECTIVE: To determine the maternal and perinatal outcome after expectant management of severe pre-eclampsia between 24 and 34 weeks of gestation. METHOD: The maternal and fetal status was monitored by an intensive, non-invasive method among 94 women with severe pre-eclampsia between 24 and 34 weeks of gestation who were scheduled for expectant management in the OICU at a tertiary care center. Pregnancy prolongation and maternal and perinatal morbidity and mortality were analyzed by the Student 't' test and the Mann-Whitney U test. RESULTS: The days of pregnancy prolongation and perinatal mortality were significantly higher among those managed at <30 weeks. Increasing gestational age correlated with a reduction of RDS. Maternal morbidities were significantly higher among those managed at <28 weeks. But, there was no maternal mortality. CONCLUSION: Expectant management of severe pre-eclampsia at 30-34 weeks in a tertiary care center of a developing country is associated with good perinatal outcome and risk reduction for the mother.

Percutaneous tension band wiring for patellar fractures.

PURPOSE: To evaluate outcome of percutaneous tension band wiring for transverse fractures of the patella. METHODS: 16 men and 7 women aged 27 to 65 (mean, 40) years underwent percutaneous tension band wiring for transverse fractures of the patella with a displacement of >3 mm. Pain, operating time, mobility, functional score, and complications were evaluated. RESULTS: 20 patients underwent successful percutaneous tension band wiring. The remaining 3 patients in whom closed reduction failed underwent open reduction and tension band wiring. The mean operating time was 46 (range, 28-62) minutes. The mean follow-up period was 20 (range, 15-30) months. At the latest follow-up, all patients had regained full extension. The objective score was excellent in 20 patients and good in 3, whereas the subjective score was excellent in 17, good in 5, and fair in one. All patients had radiological union at week 8. One patient had patellofemoral arthritis (secondary to a postoperative articular step). Two patients developed superficial infections, which resolved after antibiotic therapy. Mean thigh muscle wasting was 0.7 (range, 0.4-1) cm. Three patients encountered hardware problems (impingement/irritation of the skin over the knee) necessitating implant removal. CONCLUSION: Percutaneous tension band wiring is a viable option for transverse fractures of the patella.