Assisted feeding is more reliable for infants with clefts--a randomized trial. Infant orthopedics in UCLP: effect on feeding, weight, and length: a randomized clinical trial (Dutchcleft). Effectiveness of two feeding methods in improving energy intake and growth of infants with cleft palate: a randomized study. Breast feeding or spoon feeding after cleft lip repair: a prospective, randomised study. The nature of feeding in infants with unrepaired cleft lip and/or palate compared with healthy noncleft infants. Diclofenac analgesia following cleft palate surgery. Maternal drug use and infant cleft lip/palate with special reference to corticoids. UNICEF/WHO baby-friendly hospital initiative: does the use of bottles and pacifiers in the neonatal nursery prevent successful breastfeeding? Neonatal Study Group. First trimester exposure to corticosteroids and oral clefts. Maternal corticosteroid use and orofacial clefts. A pilot study to assess the viability of a randomised controlled trial of methods of supplementary feeding of breast-fed pre-term babies.
To compare the effectiveness of squeezable and rigid feeding bottles for infants with clefts.
                Patients were randomly assigned at birth to feeding with a squeezable bottle (assisted feeding) or to feeding with a rigid bottle and were followed for 1 year. The data were analyzed on the basis of intention to treat.
                The trial was conducted within the existing arrangements for hospital and home care for children with clefts within the National Health Service in the north of England.
                The patients were 101 consecutively born children with cleft lip and/or palate who were otherwise healthy. All patients completed the trial. Two were excluded from the analysis when unrelated developmental problems became apparent.
                Anthropometric measures-nude weight, crown-heel length (CHL), and occipito-frontal circumference (OFC)-were recorded.
                There were statistically significant differences between the two groups in weight at 12 months (p = .038, with an adjusted mean difference of 0.43 kg) and in head circumference (p = .004 with an adjusted mean difference of 0.77 cm), indicating increased growth in the squeezable bottle group. The difference in CHL was not significant at conventional levels (p = .082). Whereas 25 of 52 (48%) rigid bottles required modification by the health visitor, this was needed for only 4 of 49 (8%) squeezable bottles. There was a highly significant difference when numbers of modifications for each method were compared (p < .0001). Despite modifications, six infants feeding with a rigid bottle (11%) were transferred to a squeezable bottle due to problems with feeding, but none were transferred from squeezable to rigid bottles. Thus, the squeezable bottle generally appeared to be a more satisfactory method, requiring less support or intervention after initial instruction.
                Both feeding methods achieved similar anthropometric outcomes, with a beneficial effect on head circumference and weight in the assisted feeding group. We recommend that this last observation be treated with caution. The squeezable bottles were easier to use, and we recommend that they be routinely prescribed. To study the effects of infant orthopedics (IO) on feeding, weight, and length.
                Prospective two-arm randomized controlled trial in three academic Cleft Palate Centers. Treatment allocation was concealed and performed by means of a computerized balanced allocation method.
                Cleft Palate Centers of Amsterdam, Nijmegen, and Rotterdam, the Netherlands.
                Infants with complete unilateral cleft lip and palate (UCLP), no other malformations.
                One group (IO+) wore passive maxillary plates during the first year of life, but the other group (IO-) did not. All other interventions were the same for both groups.
                Bottle feeding velocity (mL/min) at intake, 3, 6, 15, and 24 weeks (T0 to T24); weight-for-age, length-for-age, and weight-for-length using z scores; reference values from the Netherlands' third nationwide survey on growth.
                Feeding velocity increased with time from 2.9 to 13.2 mL/min in the IO- group and from 2.6 to 13.8 mL/min in the IO+ group; no significant differences were found between groups. Weight-for-age, length-for-age, and weight-for-length (z scores) did not differ significantly between groups, but overall the infants with unilateral cleft lip and palate in both groups had significantly lower mean z scores for weight-for-age and height-for-age than the reference during the first 14 months, and had lower mean values for weight-for-length after soft palate closure.
                Infant orthopedics with the aim of improving feeding and consequent nutritional status in infants with unilateral cleft lip and palate can be abandoned. To compare two feeding methods advocated for infants with cleft palate: (a) a squeezable plastic container with a narrow, long crosscut nipple (squeezable cleft palate nurser); and (b) a standard nipple with a crosscut (crosscut nipple). The effectiveness of a nutrition intervention protocol for these infants was also documented.
                Thirty-one infants (median age = 15 days) were randomized to one of two feeding methods (18 infants, squeezable cleft lip/palate nurser; 13 infants, crosscut nipple) within sex (21 boys, 10 girls) and palatal defect (22 cleft lip and palate, 9 isolated cleft palate) categories. The intervention included feeding technique instructions, nutrition counseling at each clinic visit, use of the same 20 kcal/oz standard formula for 12 months, and introduction of infant and soft table foods at 6 months. Four-day food records and growth data were obtained.
                Mean energy and protein intakes at 3 and 6 months of age and growth measurements during the first 18 months of life were obtained.
                A repeated measures analysis of variance for intakes was performed with time as the repeated measure and feeding method as the covariable. Similar analyses were completed for growth measures with sex and feeding method as covariates.
                Mean energy intake at 3 and 6 months of age (P = .24) and growth measurements during the first 18 months of life (P values: weight gain [grams per day], .73; weight, .21; length, .07; head circumference, .18; triceps and subscapular skinfolds and mid-arm circumference, .47, .48, and .69, respectively) were not significantly different. Both feeding methods were effective in supporting normal growth.
                With adequate instruction related to the use of either feeding technique and close nutrition follow-up early in infancy, a dietitian or other health care practitioner may advise the use of either feeding method. These data support the need for feeding and nutrition education and early nutrition intervention. It has been a tradition for plastic surgeons to withhold breast feeding from babies after cleft lip repair to prevent wound disruption. A prospective, randomised trial of 40 infants showed that early postoperative breast feeding after cleft lip repair is safe, results in more weight gain at 6 weeks after surgery (P < 0.01) and is more economical than spoon feeding. Feeding difficulties are reported widely in infants with cleft lip and/ or palate. There is, however, a paucity of objective information about the feeding patterns of these infants. This study compared patterns of feeding in infants with unrepaired cleft lip and palate with healthy noncleft infants of a similar age.
                North Thames Regional Cleft Centre. The noncleft cohort was recruited from West Middlesex University Hospital, a general hospital with similar demographics.
                Fifty newborn infants with nonsyndromic complete unilateral cleft lip and palate or a cleft of the soft and at least two thirds of the hard palate who were referred to the North Thames Regional Cleft Centre participated. Parents of 20 randomly selected, noncleft infants agreed to participate.
                Feeding patterns were rated using the Neonatal Oral Motor Assessment Scale. Additional objective information was collected using the Great Ormond Street Measurement of Infant Feeding (Masarei et al., 2001; Masarei, 2003).
                Infants with nonsyndromic complete unilateral cleft lip and palate or a cleft of the soft and at least two thirds of the hard palate had less efficient sucking patterns than their noncleft peers had. They used shorter sucks (mean difference, 0.30 second; p < .0005), a faster rate of sucking (mean difference, 34.20 sucks/second; p < .0005), higher suck-swallow ratios (mean difference, 1.87 sucks/swallow; p < .0005), and a greater proportion of intraoral positive pressure generation (mean difference, 45.97% positive pressure; p < .0005).
                This study demonstrated that the sucking patterns of infants with nonsyndromic complete unilateral cleft lip and palate or a cleft of the soft and at least two thirds of the hard palate differ from those of their noncleft peers. This prospective study looked at the postoperative hemorrhage risk associated with the use of diclofenac following cleft palate repair.
                Twenty consecutive children (6 months to 9 years of age) requiring repair of the hard or soft palate were included.
                Single per rectum doses of diclofenac were given at 1 mg/kg following cleft palate repair, with additional doses every 12 hours.
                The use of the nonsteroidal anti-inflammatory drug, diclofenac, for postoperative analgesia is well established for many types of surgery. The authors find that twice daily diclofenac rectal suppositories provide very good analgesia postcleft palate repair. This, combined with supplemental oral paracetamol, obviates the need for opiates, resulting in alert infants who feed well and are suitable for early discharge. To study the association between maternal drug use in early pregnancy and orofacial cleft in the infant.
                Register analysis based on prospectively collected information.Patients: All delivered women in Sweden July 1, 1995, through December 31, 2001.
                Presence of orofacial cleft in infant.
                Prospective information on maternal drug use during the first trimester, as reported in early pregnancy, was studied in 1142 infants with orofacial clefts, isolated or with other malformations, excluding chromosome anomalies. Any drug use was not associated with clefts (odds ratio [OR] = 0.98, 95% confidence interval [95% CI] = 0.85 to 1.13), with isolated clefts (OR = 0.92) with isolated median cleft palate (OR = 1.03, 95% CI = 0.79 to 1.36) or with isolated cleft lip with or without cleft palate (OR = 0.86, 95% CI = 0.71 to 1.05). Reported use of multivitamins, folic acid, or B(12) was not associated with a decrease in orofacial cleft risk (OR = 1.00, 95% CI = 0.63 to 1.52). ORs above 2 were seen for some drugs: sulfasalazine, naproxen, and anticonvulsants, but only a few exposed cases occurred. An association between glucocorticoid use and infant cleft was indicated and seemed to be strongest for median cleft palate.
                Maternal drug use seems to play only a small role for the origin of orofacial clefts, at least in Sweden. To promote breastfeeding, UNICEF/WHO have launched the "baby-friendly hospital initiative" focusing on hospital care routines during delivery and the first days of life. In industrialised countries, two aspects of the initiative have raised controversy: how do restriction of supplemental feedings and ban of bottles and pacifiers affect long-term breastfeeding performance? From ten centres 602 healthy newborns were randomly assigned either to a UNICEF group with restrictive fluid supplements and avoidance of bottles and pacifiers during the first 5 days of life, or to a standard group with conventional feeding practice. Breastfeeding was encouraged in both groups. The main study endpoints were the prevalences of breast-feeding on day 5, and after 2, 4 and 6 months. Of the newborns 46% violated the UNICEF protocol, mostly because of maternal requests to give a pacifier or supplements by bottle. In the standard group, the drop-out rate was 9.7%. No significant differences in breastfeeding frequency and duration could be found: (UNICEF vs standard) day 5: 100% vs 99%; 2 months: 88% vs 88%; 4 months: 75% vs 71%; 6 months: 57% vs 55%. Inclusion of drop-outs due to pacifier use did not alter the results. Conclusion: In our study population fluid supplements offered by bottle with or without the use of pacifiers during the first 5 days of life were not associated with a lower frequency or shorter duration of breastfeeding during the first 6 months of life. The possible association between oral cleft in the newborn and maternal exposure to corticoids during pregnancy is still controversial. The aim of this study was to test this association by a case-control analysis using the large multicentric MADRE database.
                The MADRE database is a collection of information on malformed infants with a history of maternal first-trimester drug exposure. Nine malformation registries participate in the data collection. Cases were defined as infants presenting with a cleft palate or cleft lip, and exposure was defined by the use of corticosteroids during the first trimester of pregnancy.
                After 12 years of data collection, the database includes data on 11,150 malformed infants. A slight association is observed between exposure to corticoids for systemic use and the occurrence of cleft lip with or without cleft palate (OR, 2.59; 95% CI, 1.18-5.67).
                If the observed association is real, an interpretation is suggested, based on a likely interaction between corticosteroids and environmental dioxins. It is indeed possible that human fetuses may become sensitive to the teratogenic effect of corticosteroids when they are exposed in utero to environmental pesticides as well.
                Copyright 2003 Wiley-Liss, Inc. The purpose of this study was to examine whether maternal corticosteroid use during pregnancy is associated with delivering an infant with an orofacial cleft.
                This study included data on deliveries from the National Birth Defects Prevention Study, which is a population-based case-control study. Exposures were assessed by telephone interviews for mothers of 1141 cases with cleft lip +/- cleft palate (CLP), 628 with cleft palate (CP), and 4143 controls.
                Mothers of 33 infants with CLP (2.9%), mothers of 6 infants with CP (1.0%), and 72 control subjects (1.7%) reported corticosteroid use from 4 weeks before through 12 weeks after conception. The crude odds ratio for "any" vs "no" use was 1.7 (95% CI, 1.1-2.6) for CLP and 0.5 (0.2-1.3) for CP. When analyzed by route of administration and medication components, odds ratios for CLP tended to be elevated, and odds ratios for CP tended to be close to 1.
                Our results suggest a moderately increased risk of CLP among women who use corticosteroids during early pregnancy. to compare the impact of two methods of supplementary feeding of pre-term babies (bottle vs cup) on subsequent breast feeding and to assess the feasibility of using a randomised controlled trial (RCT) to investigate the topic.
                small scale prospective RCT. Data on breast feeding, as defined as the exclusive method of feeding, were collected. A range of relevant bio-data was also collected and their impact on breast feeding assessed.
                a special care baby unit in a District General Hospital in the UK.
                over a three-month period, all pre-term babies (32-37 weeks' gestation) who fulfilled the inclusion criteria and has been born to mothers who had expressed a pre-partum desire to breast feed, who had consented to take part, were included (n=14).
                the eligible babies were randomly allocated to supplementary feeding of breast milk, via either a cup or a bottle. Whether or not the baby was being breast fed at discharge was noted.
                the study suggested that this RCT framework is a viable method of investigating baby feeding. Because of the small-scale nature of the project, the actual database must be treated with extreme caution. No significant differences were found between the two groups in terms of breast feeding. However, the mothers reported high levels of support and also the breast-feeding rates were above the national averages. These two findings could have contributed to the non-significant results observed in this analysis.
                if the present findings could be supported by further research, then the non-significant results relating method of supplementary feeds to subsequent breast feeding could be explained by reference to three factors. Firstly, there is, in fact, no real effect of method of supplementary feeding and subsequent breast feeding; secondly, the method adopted differed from existing research and thus may be expected to produce non-corroborative results; and finally, the overall levels of breast feeding within the Unit generally were higher than the national average. The relevance of the RCT for investigating this subject is also discussed with reference to the present data set. Further experimental work to develop these ideas and to identify causal links is required.
                Copyright 2001 Harcourt Publishers Ltd.
Squeezable bottles appear easier to use than rigid feeding bottles for babies born with clefts of the lip and/or palate, however, there is no evidence of a difference in growth outcomes between the bottle types. There is weak evidence that breastfeeding is better than spoon-feeding following surgery for cleft. There was no evidence to suggest that maxillary plates assist growth in babies with clefts of the palate. No evidence was found to assess the use of any types of maternal advice and/or support for these babies.