Randomised controlled trial of an aggressive nutritional regimen in sick very low birthweight infants

AIMS—To improve energy intake in sick very low birthweight (VLBW) infants; to decrease growth problems, lessen pulmonary morbidity, shorten hospital stay, and avoid possible feeding related morbidity. Morbidity in VLBW infants thought to be associated with parenteral and enteral feeding includes bronchopulmonary dysplasia, necrotising enterocolitis, septicaemia, cholestasis and osteopenia of prematurity.METHODS—A prospective randomised controlled trial (RCT) comparing two types of nutritional intervention was performed involving 125 sick VLBW infants in the setting of a regional neonatal intensive care unit. Babies were randomly allocated to either an aggressive nutritional regimen (group A) or a control group (group B). Babies in group B received a conservative nutritional regimen while group A received a package of more aggressive parenteral and enteral nutrition. Statistical analysis was done using Student''s t test, the Mann-Whitney U test, the χ² test and logistic regression.RESULTS—There was an excess of sicker babies in group A, as measured by initial disease severity (P <0.01), but mean total energy intakes were significantly higher (P <0.001) in group A at days 3 to 42 while receiving total or partial parenteral nutrition. Survival and the incidences of bronchopulmonary dysplasia, septicaemia, cholestasis, osteopenia and necrotising enterocolitis were similar in both groups. Growth in early life and at discharge from hospital was significantly better in babies in group A. There were no decreases in pulmonary morbidity or hospital stay.CONCLUSION—Nutritional intake in sick VLBW infants can be improved without increasing the risk of adverse clinical or metabolic sequelae. Improved nutritional intake resulted in better growth, both in the early neonatal period and at hospital discharge, but did not decrease pulmonary morbidity or shorten hospital stay.     

Effects of music therapy for children and adolescents with psychopathology: a meta-analysis

BACKGROUND: The objectives of this review were to examine the overall efficacy of music therapy for children and adolescents with psychopathology, and to examine how the size of the effect of music therapy is influenced by the type of pathology, client's age, music therapy approach, and type of outcome. METHOD: Eleven studies were included for analysis, which resulted in a total of 188 subjects for the meta-analysis. Effect sizes from these studies were combined, with weighting for sample size, and their distribution was examined. RESULTS: After exclusion of an extreme positive outlying value, the analysis revealed that music therapy has a medium to large positive effect (ES =.61) on clinically relevant outcomes that was statistically highly significant (p <.001) and statistically homogeneous. No evidence of a publication bias was identified. Effects tended to be greater for behavioural and developmental disorders than for emotional disorders; greater for eclectic, psychodynamic, and humanistic approaches than for behavioural models; and greater for behavioural and developmental outcomes than for social skills and self-concept. CONCLUSIONS: Implications for clinical practice and research are discussed.     

A randomized trial of two dexamethasone regimens to reduce side-effects in infants treated for chronic lung disease of prematurity

OBJECTIVE: Dexamethasone has been widely used to reduce the incidence of chronic lung disease in preterm infants. However side-effects are common, and the ideal dose of dexamethasone has not been identified. We aimed to determine whether an individualized course of dexamethasone given to preterm babies at risk of chronic lung disease reduced the total dose of dexamethasone administered and reduced side-effects compared with a standard 42-day course. METHODS: Thirty-three infants in a regional neonatal unit with a birthweight of < or =1250 g who required mechanical ventilation at 7 days of age were randomly assigned to a 42-day course of dexamethasone or an individualized course tailored to their respiratory status. The primary outcome was linear growth at 36 weeks corrected gestational age. RESULTS: Infants in the individualized course received a 40% lower total dose of dexamethasone. However, there was no difference between the two groups in linear growth or in the incidence of any other side-effects of treatment. There was also no difference in respiratory status or neurodevelopmental outcome. CONCLUSION: The individualized course of dexamethasone used in this study reduced the total dose of dexamethasone administered but did not significantly reduce side-effects of treatment or alter outcome in infants at risk of chronic lung disease.     

Heat Loss Prevention (HeLP) in the delivery room: A randomized controlled trial of polyethylene occlusive skin wrapping in very preterm infants

OBJECTIVES: To determine if polyethylene occlusive skin wrapping of very preterm infants prevents heat loss after delivery better than conventional drying and to evaluate if any benefit is sustained after wrap removal. STUDY DESIGN: This was a randomized controlled trial of infants <28 weeks' gestation. The experimental group was wrapped from the neck down. Only the head was dried. Control infants were dried completely. Rectal temperatures were compared on admission to the neonatal intensive care unit immediately after wrap removal and 1 hour later. RESULTS: Of 55 infants randomly assigned (28 wrap, 27 control), 2 died in the delivery room and 53 completed the study. Wrapped infants had a higher mean rectal admission temperature, 36.5 degrees C (SD, 0.8 degrees C), compared with 35.6 degrees C (SD, 1.3 degrees C) in control infants ( P = .002). One hour later, mean rectal temperatures were similar in both groups (36.6 degrees C, SD, 0.7 degrees C vs 36.4 degrees C, SD, 0.9 degrees C, P = .4). Size at birth was an important determinant of heat loss: Mean rectal admission temperature increased by 0.21 degrees C (95% CI, 0.04 to 0.4) with each 100-g increase in birth weight. CONCLUSIONS: Polyethylene occlusive skin wrapping prevents rather than delays heat loss at delivery in very preterm infants.     

A randomised controlled treatment trial of two forms of family therapy in adolescent anorexia nervosa: a five-year follow-up

BACKGROUND: There is growing evidence that family therapy is an effective treatment for adolescent anorexia nervosa. This study aimed to ascertain the long-term impact of two forms of outpatient family intervention previously evaluated in a randomised controlled trial (RCT). METHOD: A five-year follow-up was conducted on a cohort of 40 patients who had received either 'conjoint family therapy' (CFT) or 'separated family therapy' (SFT). All patients were traced and 38 agreed to be reassessed (29 interviewed in person, 3 completed telephone interviews, 6 completed questionnaires and/or agreed for parents/GP to be interviewed). RESULTS: Overall there was little to distinguish the two treatments at 5 years, with more than 75% of subjects having no eating disorder symptoms. There were no deaths in the cohort and only 8% of those who had achieved a healthy weight by the end of treatment reported any kind of relapse. Three patients developed bulimic symptoms but only one to a degree warranting a diagnosis of bulimia nervosa. The one difference between the treatments was in patients from families with raised levels of maternal criticism. This group of patients had done less well at the end of treatment if they had been offered conjoint family meetings. At follow-up this difference was still evident, as shown in the relative lack of weight gain since the end of outpatient treatment. CONCLUSIONS: This study confirms the efficacy of family therapy for adolescent anorexia nervosa, showing that those who respond well to outpatient family intervention generally stay well. The study provides further support for avoiding the use of conjoint family meetings at least early on in treatment when raised levels of parental criticism are evident.     

The effect of in-hospital developmental care on neonatal morbidity,growth and development of preterm Taiwanese infants: A randomized controlled trial

Introduction

Intervention studies of developmental care for preterm infants in Western societies have shown early but unsustainable effects on child outcomes, however only a limited of studies have examined if developmental care interventions produce similar effects in Eastern cultural contexts.

Aims

To examine the effectiveness of in-hospital developmental care on neonatal morbidity, growth and development of preterm infants with very low birth weight (VLBW; birth weight < 1500 g) in Taiwan.

Methods

One hundred and seventy-eight VLBW preterm infants were randomly assigned to the clinical trial during hospitalization at three hospitals in Taiwan; the control group received five sessions of standard child-focused developmental care and the intervention group received five sessions of child- and parent-focused developmental care. Sixty-two normal term infants were also included as a comparison group. Infants were examined for morbidity, growth and developmental outcomes at term age.

Results

At study entry, more infants in the intervention group were twins or multiples than those in the control group (29% vs. 16%, p = 0.05). After adjusting for birth set, the intervention group had lower incidences of stage II–III retinopathy (odds ratio [OR] = 0.34 [95% confidence interval (CI): 0.15–0.79]; p = 0.01) and feeding desaturation (OR = 0.32 [95% CI: 0.10–1.00]; p = 0.05) and had greater daily weight gains (difference = 2.0 g/day [95% CI: 0–4.0 g/day]; p = 0.05) as compared with the control group. However, the intervention and control groups did not differ in any of the neurodevelopmental measures.

Conclusions

In-hospital developmental care has short-term benefits for Taiwanese VLBW preterm infants in reducing the risk of retinopathy and feeding desaturation as well as in enhancing weight gains at term age.     

A randomised controlled trial of delayed cord clamping in very low birth weight preterm infants

This study was carried out to assess the feasibility of late cord clamping of 45 s in preterm infants delivered mainly by caesarean section and the effects on post-partal adaptation and anaemia of prematurity. Prior to delivery, 40 infants of <33 gestational weeks were randomised to either 20 s or 45 s of late cord clamping. After the first shoulder was delivered, oxytocin was given intravenously to the mother in order to enhance placento-fetal transfusion while the infant was held below the level of the placenta. The 20 infants in group 1 (20 s) had a mean birth weight of 1070 g and a mean gestational age of 29 + 4/7 weeks versus 1190 g and 30 weeks in group 2 (45 s). On day 42 of life there were ten infants without transfusions in group 2 versus three in group 1 (P < 0.05). Out of the 20 infants in group 1, 19 and 15/19 in group 2 were delivered by caesarean section. There were no significant differences in Apgar scores, temperature on admission, heart rate, blood pressure and requirements for artificial ventilation. Conclusion Delayed cord clamping of 45 s is feasible and safe in preterm infants below 33 weeks of gestation. It is possible to perform the procedure at caesarean section deliveries and it should be performed whenever possible. It reduces the need for packed red cell transfusions during the first 6 weeks of life. Received: 10 February 2000 / Accepted: 12 April 2000     

Preliminary analysis of developmental observations in a survey of morbidity in infants

Assessment of developmental status, particularly the identification of severe developmental disability, is an important outcome measure of the effect of many types of perinatal and early infant health programs. This report examines the feasibility of the use of a brief battery of developmental observations by a trained lay interviewer in the home as part of a large-scale survey of morbidity in one-year-old infants. A total of 4989 home visits was completed, and of these 3179 were to infants of low birthweight. The interviewers obtained a high degree of cooperation from the infants in this setting. Internal consistency, as measured by coefficient alpha and item-total score correlations, and inter-rater agreement for each observation on a small random sample (137) of revisits indicated reliability sufficient for research purposes for all except receptive language items. Good agreement was found between diagnostic and health are variables obtained through the interview with the mother and a developmental status classification based on the observations. While preliminary, these results are of importance in the design of infant follow-up programs.     

A randomized controlled trial of positioning treatments in infants with positional head shape deformities

Background: Randomized controlled trials of treatment for deformational plagiocephaly and brachycephaly have been lacking in the literature. Methods: Infants (n = 126) presenting to a plagiocephaly clinic were randomized to either positioning strategies or to positioning plus the use of a Safe T Sleep? positioning wrap. Head shape was measured using a digital photographic technique, and neck function was assessed. They were followed up at home 3, 6 and 12 months later. Results: There was no difference in head shape outcomes for the two treatment groups after 12 months of follow‐up, with 42% of infants having head shapes in the normal range by that time. Eighty per cent of children showed good improvement. Those that had poor improvement were more likely to have both plagiocephaly and brachycephaly and to have presented later to clinic. Conclusions: Most infants improved over the 12‐month study period, although the use of a sleep positioning wrap did not increase the rate of improvement.     

A randomised, controlled trial of once daily and multi-dose daily gentamicin in young Kenyan infants

Aims: To test the suitability of a simple once daily (OD) gentamicin regimen for use in young infants where routine therapeutic drug monitoring is not possible. Methods: In an open, randomised, controlled trial, infants with suspected severe sepsis admitted to a Kenyan, rural district hospital received a novel, OD gentamicin regimen or routine multi-dose (MD) regimens. Results: A total of 297 infants (over 40% ⩽7 days) were randomised per protocol; 292 contributed at least some data for analysis of pharmacological endpoints. One hour after the first dose, 5% (7/136) and 28% (35/123) of infants in OD and MD arms respectively had plasma gentamicin concentrations <4 µg/ml (a surrogate of treatment inadequacy). Geometric mean gentamicin concentrations at this time were 9.0 µg/ml (95% CI 8.3 to 9.9) and 4.7 µg/ml (95% CI 4.2 to 5.3) respectively. By the fourth day, pre-dose concentrations ⩾2 µg/ml (a surrogate of potential treatment toxicity) were found in 6% (5/89) and 24% (21/86) of infants respectively. Mortality was similar in both groups and clinically insignificant, although potential gentamicin induced renal toxicity was observed in <2% infants. Conclusions: A "two, four, six, eight" OD gentamicin regime, appropriate for premature infants and those in the first days and weeks of life, seems a suitable, safe prescribing guide in resource poor settings.     

The effectiveness of video interaction guidance in parents of premature infants: A multicenter randomised controlled trial

ABSTRACT: BACKGROUND: Studies have consistently found a high incidence of neonatal medical problems, premature births and low birth weights in abused and neglected children. One of the explanations proposed for the relation between neonatal problems and adverse parenting is a possible delay or disturbance in the bonding process between the parent and infant. This hypothesis suggests that due to neonatal problems, the development of an affectionate bond between the parent and the infant is impeded. The disruption of an optimal parent-infant bonding -on its turn- may predispose to distorted parent-infant interactions and thus facilitate abusive or neglectful behaviours. Video Interaction Guidance (VIG) is expected to promote the bond between parents and newborns and is expected to diminish non-optimal parenting behaviour. Methods/design This study is a multi-center randomised controlled trial to evaluate the effectiveness of Video Interaction Guidance in parents of premature infants. In this study 210 newborn infants with their parents will be included: n = 70 healthy term infants (>37 weeks GA), n = 70 moderate term infants (32-37 weeks GA) which are recruited from maternity wards of 6 general hospitals and n = 70 extremely preterm infants or very low birth weight infants (<32 weeks GA) recruited by the NICU of 2 specialized hospitals The participating families will be divided into 3 groups: a reference group (i.e. full term infants and their parents, receiving care as usual), a control group (i.e. premature infants and their parents, receiving care as usual) and an intervention group (i.e. premature infants and their parents, receiving VIG). The data will be collected during the first six months after birth using observations of parent-infant interactions, questionnaires and semi-structured interviews. Primary outcomes are the quality of parental bonding and parent-infant interactive behaviour. Parental secondary outcomes are (posttraumatic) stress symptoms, depression, anxiety and feelings of anger and hostility. Infant secondary outcomes are behavioral aspects such as crying, eating, and sleeping. DISCUSSION: This is the first prospective study to empirically evaluate the effect of VIG in parents of premature infants. Family recruitment is expected to be completed in January 2012. First results should be available by 2012. Trail registration number NTR3423.     

A randomised controlled trial of early insulin therapy in very low birth weight infants, "NIRTURE" (neonatal insulin replacement therapy in Europe)

Background

Studies in adult intensive care have highlighted the importance of insulin and improved glucose control on survival, with 32% reduction in mortality, 22% reduction in intensive care stay and halving of the incidence of bacteraemia. Very low birth weight infants requiring intensive care also have relative insulin deficiency often leading to hyperglycaemia during the first week of life. The physiological influences on insulin secretion and sensitivity, and the potential importance of glucose control at this time are not well established. However there is increasing evidence that the early postnatal period is critical for pancreatic development. At this time a complex set of signals appears to influence pancreatic development and β cell survival. This has implications both in terms of acute glucose control but also relative insulin deficiency is likely to play a role in poor postnatal growth, which has been associated with later motor and cognitive impairment, and fewer β cells are linked to risk of type 2 diabetes later in life.

Methods

A multi-centre, randomised controlled trial of early insulin replacement in very low birth weight babies (VLBW, birth weight < 1500 g). 500 infants will be recruited from 10 centres in the UK and Europe. Babies will be randomised to receive a continuous insulin infusion (0.05 units/kg/h) or to receive standard neonatal care from the first day of life and for the next 7 days. If blood glucose (BG) levels fall infants will receive 20% dextrose titrated to maintain normoglycaemia (4–8 mmol/l). If BG is consistently above 10 mmol/l babies will receive standard treatment with additional insulin infusion. The primary end point will be mortality on or before expected date of delivery, secondary end points will be markers of morbidity and include episodes of sepsis, severity of retinopathy, chronic lung disease and growth.

Trial Registration

Current Controlled Trials ISRCTN78428828. EUDRACT Number 2004-002170-34