Promoting secure attachment, maternal mood and child health in a vulnerable population: a randomized controlled trial

OBJECTIVE: To evaluate the efficacy of an early home-based intervention on the quality of maternal-infant attachment, maternal mood and child health parameters in a cohort of vulnerable families. METHODOLOGY: A total of 181 families were recruited to the study in the immediate postnatal period on the basis of a self report questionnaire relating to known family vulnerability factors. Families were assigned randomly to intervention (90), or control (91) groups. The intervention group received a series of home visits from a child health nurse (weekly to 6 weeks, fortnightly to 3 months), with a subgroup receiving home based short-term dynamic therapy from a social worker. Parent/family function was assessed at inception and at 4 months by the Parenting Stress Index and the Edinburgh Post Natal Depression Scale. At 4 months the quality of the home environment was assessed, utilizing the Home Observation for Measurement of the Environment Inventory, as were child and family health parameters and satisfaction with the community child health service. RESULTS: At 4 month follow-up, 160 families (80 intervention, 80 control) were available for assessment. The intervention improved family functioning at 4 months. All aspects of the home environment, including the quality of maternal-infant attachment and mothers' relationship with their child, were significantly enhanced. In particular, significant and positive differences were found in parenting with the intervention group feeling less restrictions imposed by the parenting role, greater sense of competence in parenting, greater acceptability of the child, and the child being more likely to provide positive reinforcement to the parent. Early differences in maternal mood were not maintained at 4 months. Various child health parameters were enhanced including immunization status, fewer parent-reported injuries and bruising, and researcher confirmed lack of smoking in the house or around the infant. The families were consistently more satisfied with their community health service. CONCLUSIONS: This form of early home based intervention targeted to vulnerable families promotes an environment conducive for infant mental and general health and hence long-term psychological and physical well-being, and is highly valued by the families who receive it.     

'Right from the Start': randomized trial comparing an attachment group intervention to supportive home visiting

Background:  Infant attachment security is a protective factor for future mental health, and may be promoted by individual interventions. Given service demands, it is important to determine if a group-based intervention for parents could be used to enhance infant attachment security.
Methods:  In a randomized trial involving 76 mothers, an 8-session attachment group called 'Right from the Start' (RFTS) was compared to home visiting (treatment as usual).
Results:  Intention-to-treat analyses indicated no significant differences between RFTS and home visiting, with both groups showing small improvements in infant attachment security and maternal sensitivity. RFTS cost significantly less and was more cost effective than home visiting, and was not significantly different in terms of participation ratings, client satisfaction, or follow-up service requests. There was differential compliance for the two interventions, with 89% and 58% attending 4 or more sessions of home visiting and RFTS, respectively. Secondary analyses considering non-attenders as a separate (nonrandomized) group indicated a significant advantage for those who attended RFTS on pre-test/post-test maternal sensitivity change scores ( d  = .52) and pre-test/6-month follow-up infant attachment security changes scores ( d  = .55).
Conclusions:  RFTS is as effective as home visiting in improving infant attachment security and maternal sensitivity. The effect sizes for RFTS were comparable to those of individual attachment interventions in this relatively inexpensive, community-based group intervention.     

A randomized controlled trial of telephone calls to young patients with poorly controlled type 1 diabetes

OBJECTIVE: To determine if scheduled telephone calls from a pediatric diabetes educator to children who have type 1 diabetes improve hemoglobin A1c (HbA1c) level, hospital admissions, diabetes knowledge, compliance, and psychological well-being. RESEARCH DESIGN AND METHODS: A randomized controlled trial of 123 young subjects (mean age 11.9 yr, 69 male) with type 1 diabetes (mean duration 3.65 yr). For 7 months, the intervention group held bimonthly 15-30 min scheduled supportive telephone discussions. The primary outcome was change in the HbA1c level. Admission rates and changes in diabetes knowledge, psychological parameters, compliance, and patient perception were measured. RESULTS: There was no significant difference between the treatment and control groups either before or after the intervention. The mean HbA1c level in the control group increased from 8.32 to 8.82% and in the intervention group from 8.15 to 8.85% (p = 0.24). Both groups showed an increase in admissions of 0.2 per yr (p = 0.57). There was no improvement in diabetes knowledge (p = 0.34), compliance, or psychological function. The intervention group viewed their contact with the clinic as more helpful (p = 0.003). Analysis of family function did not reveal subgroups with statistically significant differences. A mean of 13 calls was made to each subject at a cost of 36 Australian dollars per child per month. CONCLUSIONS: Scheduled bimonthly phone support does not improve the HbA1c level, admission rates, diabetes knowledge, psychological function, or self-management but is perceived by patients as helpful. Further study into the effects of more frequent but shorter periods of support for patients experiencing specific difficulties is needed.     

A randomized controlled trial of early physiotherapy for high-risk infants

The aim of this study was to investigate the hypothesis that infants at high risk of cerebral palsy would benefit from early physiotherapy. In total, 105 infants with abnormal cranial ultrasound scans were randomized at around term to early physiotherapy or standard treatment (delaying physiotherapy until abnormal physical signs became apparent). At 12 and 30 months there were clinical and objective assessments. Nine infants died and nine were lost to follow-up by 12 months when 87 infants were assessed. One other child had died and three others were lost to follow-up by 30 months when 83 children were assessed. Cerebral palsy was only accurately predicted in 45 (54%) infants. There was no difference in outcome. The difficulty of predicting cerebral palsy reliably and the heterogeneity of the condition should be borne in mind when planning treatment and assessing its efficacy.     

M‐SAKHI—Mobile health solutions to help community providers promote maternal and infant nutrition and health using a community‐based cluster randomized controlled trial in rural India: A study protocol

Reduction of childhood stunting is difficult to achieve by interventions that focus only on improving nutrition during infancy. Comprehensive interventions that extend through the continuum of care from pregnancy to infancy are needed. Mobile phones are now successfully being used for behaviour change communication to improve health. We present the methodology of an mHealth intervention “Mobile Solutions Aiding Knowledge for Health Improvement” (M‐SAKHI) to be delivered by rural community health workers or Accredited Social Health Activists (ASHAs) for rural women, below or up to 20 weeks of pregnancy through delivery until their infant is 12 months of age. This protocol paper describes the cluster randomized controlled trial to evaluate the effectiveness of M‐SAKHI. The primary objective of the trial is to reduce the prevalence of stunting (height‐for‐age < ?2 z‐score) in children at 18 months of age by 8% in the intervention as compared with control. The secondary objectives include evaluating the impact on maternal dietary diversity, birth weight, infant and young child feeding practices, infant development, and child morbidity, along with a range of intermediate outcomes for maternal, neonatal, and infant health. A total of 297 ASHAs, five trained counsellors, and 2,501 participants from 244 villages are participating in this study. The outcome data are being collected by 51 field research officers. This study will provide evidence regarding the efficacy of M‐SAKHI to reduce stunting in young children in rural India, and if effective, the cost‐effectiveness of M‐SAKHI.     

小儿腹泻贴治疗儿童急性腹泻的多中心随机对照研究

目的研究小儿腹泻贴在治疗儿童急性腹泻中的疗效及安全性。方法采用多中心、随机、开放、阳性药物对照等效性试验。收集2011年3月至2012年11月上海、北京、广州3所医院儿科急性腹泻患儿。随机分成试验组和对照组,分别采用小儿腹泻贴、蒙脱石散剂治疗,同时均给予口服补液盐治疗。观察治疗前后患者腹泻次数、大便性状以及相关的临床症状及体征,比较治疗第3天以及第5天的疗效,并记录药物相关不良反应。结果共有197例符合入选条件的患儿完成研究,其中试验组100例,对照组97例。两组患儿的年龄、体质量、性别、治疗前腹泻时间、治疗前大便性状和次数、治疗期呕吐次数以及脱水、发热、哭闹、食欲不振、腹胀、腹痛等情况的差异均无统计学意义（P均>0.05）;试验组第3天和第5天的治疗有效率达97%和100%,与对照组差异无统计学意义（P均>0.05）;试验组呕吐的恢复情况要优于对照组,且差异有统计学意义（P<0.05）。治疗期间未发现与药物有关的不良反应。结论小儿腹泻贴治疗儿童急性腹泻的疗效与蒙脱石散剂相同,对呕吐的疗效更优,且无不良反应。     

Effect of holding on co-regulation in preterm infants: A randomized controlled trial

Objective

To determine whether kangaroo holding of healthy preterm infants over the first eight weeks of an infant's life facilitates co-regulation of salivary cortisol between mother and infant.

Study Design

Randomized control trial. Infants were assigned to receive 1 h of daily kangaroo (skin-to-skin contact on the chest of mother) or blanket holding (dressed and held in mother's arms). A registered nurse visited mothers weekly for eight weeks to encourage holding and provide information about infant development. A control group had no holding restrictions and received weekly brief social visits.

Subjects

The study included 79 preterm infants, born between 32 and 35 weeks gestational age and were a mean of 15 days (± 5.7) at enrollment.

Outcome Measures

Co-regulation was conceptualized as progressive reduction in the absolute difference between mother and infant cortisol levels across 60 min of holding at each holding session. Mother and infant cortisol levels were measured before holding and at 30 and 60 min after holding began during three holding sessions (baseline and at two and eight weeks after study initiation). Primary analyses were conducted using hierarchical linear models.

Results

There was much variability in cortisol levels. Levels of mother and infant cortisol decreased during holding. No significant co-regulation occurred in any group at any holding session or over time.

Conclusions

Decreasing level of cortisol in both mothers and infants suggests that holding promoted the expected decline in stress hormone levels. However, supported holding methods did not differentially affect co-regulation compared to controls. Holding is pleasurable and stress may need to be present in order for mothers and infants to demonstrate co-regulation in cortisol levels.     

鼻塞双水平正压通气用于呼吸窘迫综合征早产儿拔管的临床研究

目的评价鼻塞双水平正压通气（nBiPAP）作为预防新生儿呼吸窘迫综合征（RDS）撤机失败措施的临床效应。方法采用前瞻性随机对照研究方法,选择2011年1月至2012年6月收入新生儿重症监护病房且临床诊断RDS的≤32周早产儿,经气管插管及呼吸机辅助呼吸并达到撤机标准,且于初次拔管后仍有呼吸困难而需无创通气者56例作为研究对象。研究对象随机分为nBiPAP组（27例）和鼻塞持续正压通气（nCPAP）组（29例）,比较两组改用无创通气前、后的血气分析、无创通气7 d内失败率及各种并发症的发生率。结果拔管后第一次的血气分析,nBiPAP组氧分压[（58.7±6.3）mmHg]高于nCPAP组[（55.1±5.9）mmHg],二氧化碳分压[（46.4±4.9）mm Hg]低于nCPAP组[（49.9±5.0）mmHg],差异均有统计学意义（P<0.05）。nBiPAP组无创通气7 d内的失败率为7.4%,低于nCPAP组的31.0%,差异有统计学意义（P=0.042）。两组并发症发生率差异无统计学意义。结论 nBiPAP作为预防胎龄≤32周合并RDS的早产儿撤机失败的效应优于nCPAP,且安全。     

Effect of iron supplementation during lactation on maternal iron status and oxidative stress: A randomized controlled trial

We examined the effect of iron‐containing prenatal vitamin–mineral supplements taken postpartum on biomarkers of iron status and oxidative stress. Lactating women (n = 114) were randomly assigned to consume daily one iron‐free prenatal vitamin–mineral supplement plus either 27 mg of iron or placebo for approximately 3.5 months. The placebo group took the tablets between meals, while those given iron took the tablets either with (Fe‐W) or between meals (Fe‐B). Blood and urine samples were collected before and after the supplementation period to analyze hemoglobin (Hb), ferritin, hepcidin, transferrin saturation (TfSat), total plasma iron, and biomarkers of oxidative stress (isoprostane and 8‐hydroxy‐2‐deoxyguanosine (8‐OHdG)) and inflammation (C‐reactive protein (CRP) and alpha‐1‐acid glycoprotein (AGP)). There was a trend toward a greater change in Hb among women in the Fe‐B group compared to placebo (+2.5 vs. ?3.7 g/L, respectively, p = 0.063). When the iron groups were combined, there was a greater change in Hb (+1.4 g/L) compared to placebo (p = 0.010). There were trends toward greater changes in TfSat (p = 0.087) and total plasma iron (p = 0.065) in the iron groups compared to placebo, yet no significant differences between the three groups in change in hepcidin (p = 0.291), isoprostane (p = 0.319), or 8‐OHdG (p = 0.659), nor in change in ferritin among those with elevated CRP at baseline (60% of women; p = 0.946); among those without elevated CRP (40% of women), ferritin increased more in the iron groups compared to placebo (p = 0.001). Iron consumption during lactation moderately increased iron status, particularly among women without elevated CRP, and increased Hb, but did not significantly increase oxidative stress.     

A randomized,controlled trial of a community-based support program for families of children with chronic illness: pediatric outcomes

BACKGROUND: Children with chronic illnesses have a heightened risk for mental health problems. OBJECTIVES: To develop, implement, and evaluate child outcomes of a 15-month, community-based, family-support intervention designed to reduce risk for poor adjustment and mental health problems in children with 1 of 4 chronic illnesses (diabetes mellitus, sickle cell anemia, cystic fibrosis, or moderate to severe asthma) and their mothers. DESIGN: Randomized, controlled clinical trial design with multiple measures of mental health based on both child and parent reports taken 1 year apart. SETTING: Community-based intervention linked to subspecialty and general pediatric clinics and practices in Baltimore, Md. PARTICIPANTS: One hundred thirty-six mothers and children aged 7 to 11 years with diabetes mellitus, sickle cell anemia, cystic fibrosis, or moderate to severe asthma. INTERVENTION: The program, provided by "experienced mothers" and child life specialists, included telephone contacts, face-to-face visits, and special family events. MAIN OUTCOME MEASURES: Outcomes were measured using the following instruments: the Personal Adjustment and Role Skills Scale III, the Children's Depression Inventory, the Revised Children's Manifest Anxiety Scale, and the Self-Perception Profile for Children. RESULTS: The experimental group's mean adjustment score increased over the intervention period while the control group's mean adjustment score decreased. Analysis of variance demonstrated that the intervention had a significant main effect on postintervention adjustment controlling for baseline scores (P =.01). Using a cutoff score indicating maladjustment, the percentage of experimental group children in the maladjustment range fell from 19% at baseline to 10% after the intervention; the percentage of control group children in the maladjustment range rose from 15% at baseline to 21% after the intervention. The effect of the intervention was more pronounced for children who had low physical self-esteem than for those who had moderate to high physical self-esteem at the beginning of the program. CONCLUSIONS: Our results demonstrate modest positive effects of a family support intervention in promoting the adjustment of children with selective chronic health conditions. Including child life specialists in a community-based intervention may be especially salient for children with chronic illnesses who have low physical self-esteem. The intervention had a similar outcome for all diagnostic groups, suggesting that it could be effective for children with any chronic illness and implemented in a variety of pediatric settings.     

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.     

乳糖酶添加剂对早产儿乳糖不耐受有效性和安全性的前瞻性随机对照研究

目的 探讨乳糖酶添加剂对改善早产儿乳糖不耐受的有效性和安全性.方法 选取上海交通大学医学院附属新华医院2018年1月至2019年12月收治的有乳糖不耐受症状的早产儿60例纳入研究,随机分为乳糖酶治疗组和对照组,每组30例.乳糖酶治疗组给予乳糖酶添加剂4滴(180 mg)加入早产儿配方奶或母乳中;对照组给予安慰剂,同时予...     

Nutrition,hygiene, and stimulation education to improve growth,cognitive, language,and motor development among infants in Uganda: A cluster‐randomized trial

Stunting is associated with impaired cognitive and motor function. The effect of an education intervention including nutrition, stimulation, sanitation, and hygiene on child growth and cognitive/language/motor development, delivered to impoverished mothers in Uganda, was assessed. In a community‐based, open cluster‐randomized trial, 511 mother/children dyads aged 6–8 months were enrolled to an intervention (n = 263) or control (n = 248) group. The primary outcome was change in length‐for‐age z‐score at age 20–24 months. Secondary outcomes included anthropometry and scores on the 2 developmental scales: Bayley Scales of Infant and Toddler Development‐III and the Ages and Stages Questionnaire. There was no evidence of a difference in mean length‐for‐age z‐score at 20–24 months between the 2 study groups: 0.10, 95% CI [?0.17, 0.36], p = .49. The intervention group had higher mean composite development scores than the controls on Bayley Scales of Infant and Toddler Development‐III, the mean difference being 15.6, 95% CI [10.9, 20.2], p = .0001; 9.9, 95% CI [6.4, 13.2], p = .0001; and 14.6, 95% CI [10.9, 18.2], p = .0001, for cognitive, language, and motor composite scores, respectively. The mean difference in scores from the Ages and Stages Questionnaire were 7.0, 95% CI [2.9, 11.3], p = .001; 5.9, 95% CI [1.2, 10.3], p = .01; 4.2, 95% CI [1.7, 6.7], p = .001; 8.9, 95% CI [5.3, 12.3], p = .0001; and 4.4, 95% CI [0.0, 8.8], p = .05, for communication, gross motor, fine motor, problem solving, and personal–social development, respectively. The intervention education delivered to mothers promoted early development domains in cognitive, language, and motor development but not linear growth of small children in impoverished rural communities in Uganda. Our study showed that child development may be improved with a relatively low cost intervention strategy. This trial was registered at ClinicalTrials.gov as NCT02098031.     

A comparison of magnesium sulphate and sildenafil in the treatment of the newborns with persistent pulmonary hypertension: a randomized controlled trial

The aim of this prospective, randomized and controlled study was to compare the clinical efficacy of intravenous magnesium sulfate (MgSO?) and oral sildenafil therapies with persistent pulmonary hypertension of the newborn. A total of 34 infants in the MgSO? group and 31 infants in the sildenafil group completed the study. The time to reach the adequate clinical response [defined as oxygen index (OI) level of <15, a pulmonary artery pressure of < 20 mmHg) was significantly shorter in the sildenafil group (p = 0.002). Duration of mechanical ventilation was longer and the number of the patients requiring inotropic support was higher in the MgSO? group (p = 0.001 and p = 0.002, respectively). Although among two groups the difference in OI > 5 as speculated in our hypothesis could only be found at 36?h of the treatment, sildenafil was more effective than MgSO? in the treatment of persistent pulmonary hypertension of the newborns with regard to time to adequate clinical response, duration of mechanical ventilation and support requirement with inotropic agents.