Effects of daily full-term infant skin-to-skin contact on behavior and cognition at age three - secondary outcomes of a randomized controlled trial.

BACKGROUND: Daily skin-to-skin contact (SSC) during early infancy fosters the long-term development of children born preterm. This is the first randomized controlled trial assessing the potential beneficial effects of daily SSC on executive functioning and socio-emotional behavior of children born full-term. Whether children of mothers who experienced prenatal stress and anxiety benefitted more from SSC was also explored. METHODS: Pregnant women (N = 116) were randomly assigned to a SSC or care-as-usual (CAU) condition. Women in the SSC condition were instructed to perform one hour of SSC daily from birth until postnatal week five. Prenatal stress was measured with questionnaires on general and pregnancy-specific stress and anxiety completed by the mothers in gestational week 37. At child age three, mothers filled in questionnaires on children's executive functioning, and externalizing and internalizing behavior. Analyses were performed in an intention-to-treat (ITT), per-protocol, and dose-response approach. Netherlands Trial Register: NL5591. RESULTS: In the ITT approach, fewer internalizing (95% CI = 0.11-1.00, U = 2148.50, r = .24, p = .001) and externalizing (95% CI = 0.04-2.62, t = 2.04, d = 0.38, p = .04) problems were reported in the SSC condition compared to the CAU condition. Multivariate analyses of variance did not show group differences on executive functioning. Additional analyses of covariance showed no moderations by maternal prenatal stress. CONCLUSIONS: Current findings indicate that early daily SSC in full-term infants may foster children's behavioral development. Future replications, including behavioral observations of child behavior to complement maternal reports, are warranted.

Effects of skin-to-skin contact on full-term infants' stress reactivity and quality of mother-infant interactions.

Skin-to-skin contact (SSC) between mothers and their infants has beneficial effects in both preterm and full-term infants. Underlying mechanisms are largely unknown. This randomized controlled trial assessed whether daily SSC in full-term mother-infant dyads: (1) decreases infants' cortisol and behavioral reactivity to a mild naturalistic stressor, and (2) facilitates interaction quality between infants and mothers (i.e., improved maternal caregiving behavior and mother-infant adrenocortical synchrony). Pregnant Dutch women (N = 116) were recruited and randomly allocated to an SSC or care-as-usual condition. The SSC condition performed 1 h of SSC daily, from birth until postnatal week 5. In week 5, mothers bathed the infant (known mild stressor). Infant and maternal cortisol was sampled at baseline, 25 and 40 min after bathing, and infant and maternal behavior was rated. Results did not indicate effects of SSC on infant behavioral and cortisol reactivity to the bathing session. Similarly, no effect of SSC was found on maternal caregiving behavior and mother-infant adrenocortical synchrony. In conclusion, the findings provide no evidence that daily mother-infant SSC is associated with full-term infants' behavioral and adrenocortical stress reactivity or mother-infant interaction quality. Future studies should replicate these findings and unveil other potential mechanisms underlying beneficial effects of SSC.

Daily skin-to-skin contact and crying and sleeping in healthy full-term infants: A randomized controlled trial.

This randomized controlled trial (NTR5697) examined the effects of a 5-week daily skin-to-skin contact (SSC) intervention, compared with care-as-usual, on full-term infant crying and sleeping duration during the first 12 weeks postnatally (secondary outcomes of this trial). This trial included 116 Dutch healthy mothers and their full-term infants. SSC mothers were instructed to provide 1 hr daily of SSC for the first 5 weeks postpartum. Intention-to-treat analyses revealed no group differences in infant crying (i.e., total duration and mean bout length) and sleeping (i.e., total duration and mean bout length). Per-protocol analyses, including only the SSC dyads who adhered to SSC guidelines, indicated that SSC reduced infant total crying duration and the crying bout length. Similarly, dose-response analyses indicated that more SSC minutes were associated with less infant crying (i.e., shorter total duration and bout length) and longer total sleeping duration, especially when the infant was younger. No group differences and associations were found with sleeping bout length. Mother-infant SSC, when performed regularly, may be a cost-effective intervention to reduce infant crying and potentially also extend infant sleep duration. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Daily mother-infant skin-to-skin contact and maternal mental health and postpartum healing: a randomized controlled trial.

This randomized controlled trial examined the effects of a daily hour of mother-infant skin-to-skin contact (SSC) during the first five postnatal weeks, compared to care-as-usual, on maternal depressive (primary outcome), anxiety, stress, fatigue, pain, and delivery-related post-traumatic stress symptoms (PTSS). Prenatal symptom severity and touch discomfort were examined as moderators. Mothers and full-term infants were randomly allocated to SSC or care-as-usual conditions and followed during the first postnatal year. For the total group (intention-to-treat analyses), care-as-usual mothers showed an increase of anxiety symptoms from week 2 to 12, while SSC mothers displayed a stability of anxiety symptoms. Also, care-as-usual mothers showed an initial decrease in fatigue followed by an increase, while SSC mothers showed a decrease from week 2 to 12. In per-protocol analyses, including only the SSC dyads who adhered to SSC guidelines, findings on anxiety, but not fatigue, were replicated. No SSC effects were found for depressive, stress, and pain symptoms. No moderator, dose-response, or 52-week follow-up effects were found. PTSS were low with little variation; consequently, analyses were discontinued. Daily SSC in healthy mother-infant dyads may reduce anxiety and fatigue symptoms, but not depressive, stress, and pain symptoms, during the early postpartum period. Replication studies are recommended.

Can Maternal Prenatal Self-Reported and Physiological Distress Predict Postnatal Caregiving Practices?

Maternal prenatal distress is associated with child outcomes, including health, neurocognitive, and socio-emotional development. Knowledge on underlying mechanisms is limited, yet relevant for prevention and intervention. This study investigated whether maternal prenatal distress predicts specific caregiving practices that are known for their effects on child outcomes. Caregiving practices studied were maternal caregiving quality and the initiation and course of breastfeeding and room-sharing. We hypothesized that more maternal prenatal distress would be associated with altered caregiving practices. Participants were 174 healthy mother-child dyads. During the 37th week of pregnancy maternal self-reported distress was assessed using questionnaires, and physiological stress by collecting saliva cortisol. Maternal caregiving quality was observed in postnatal week 5 during infant bathing. Weekly diaries on breastfeeding and daily diaries on room-sharing were completed during the first 6 postnatal months. In a regression analysis, no associations between maternal prenatal distress and caregiving quality were found. Multilevel analyses indicated that maternal prenatal evening cortisol was positively related to the initiation of breastfeeding and room-sharing. Replications are warranted, but these results suggest that breastfeeding and room-sharing initiation may be part of a mechanism underlying links between maternal prenatal physiological stress and child outcomes. As other prenatal cortisol markers and self-reported distress were not found to be related to the caregiving practices, it is likely that alternative mechanisms (co-)exist in explaining links between maternal prenatal distress and child outcomes. Future replication research including child outcomes and (other) potential mechanisms will inform prevention and intervention programs fostering healthy pregnancies and child development.

Daily skin-to-skin contact in full-term infants and breastfeeding: Secondary outcomes from a randomized controlled trial.

This randomized controlled trial evaluated the effect of a 5-week daily skin-to-skin contact (SSC) intervention between mothers and their full-term infants, compared with care-as-usual, on exclusive and continued breastfeeding duration during the first post-natal year. Healthy pregnant women (n = 116) from a community sample were enrolled and randomly allocated to the SSC or care-as-usual condition. SSC mothers were requested to provide one daily hour of SSC for the first five post-natal weeks. Twelve months post-partum, mothers indicated the number of exclusive and continued breastfeeding months. Multiple regression analyses were conducted using intention-to-treat, per-protocol and exploratory dose-response frameworks. In intention-to-treat analyses, exclusive and continued breastfeeding duration was not different between groups (exclusive: 3.61 ± 1.99 vs. 3.16 ± 1.77 months; adjusted mean difference 0.28, 95% confidence interval [CI] -0.33 to 0.89; p = 0.36; continued: 7.98 ± 4.20 vs. 6.75 ± 4.06 months; adjusted mean difference 0.81, 95% CI -0.46 to 2.08; p = 0.21). In per-protocol analyses, exclusive and continued breastfeeding duration was longer for SSC than care-as-usual dyads (exclusive: 4.89 ± 1.26 vs. 3.25 ± 1.80 months; adjusted mean difference 1.28, 95% CI 0.31-2.24; p = 0.01; continued: 10.81 ± 1.97 vs. 6.98 ± 4.08 months; adjusted mean difference 2.33, 95% CI 0.13-4.54; p = 0.04). Exploratory dose-response effects indicated that more SSC hours predicted longer exclusive and continued breastfeeding duration. This study demonstrates that for the total group, the 5-week daily SSC intervention did not extend exclusive and continued breastfeeding duration. However, for mothers performing a regular daily hour of SSC, this simple and accessible intervention may extend exclusive and continued breastfeeding duration by months. Future studies are required to confirm these promising findings. Trial registration: Netherlands Trial Register (NTR5697).

Is prenatal maternal distress context-dependent? Comparing United States and the Netherlands.

BACKGROUND: Maternal anxiety and depression symptoms during pregnancy can compromise a woman's well-being and affect offspring development. The present study represents a comparison of maternal late-pregnancy internalizing symptoms (i.e., depression and anxiety) between the United States of America (US) and the Netherlands. We hypothesized that women in the US would report higher levels of anxiety and depression during pregnancy compared to their Dutch counterparts, both on individual symptom indicators and overall latent distress, due to more favorable policies/accessible services relevant to perinatal health in the Netherlands. METHODS: Pregnant women were recruited at two comparable sites in the Netherlands (n = 327) and the US (n = 228). Measures included self-reports of internalizing distress and key covariates (i.e., parity, gestational, and maternal age). RESULTS: Expectant mothers in the US reported higher depressive and anxiety symptoms compared to their Dutch counterparts. Results were consistent across individual internalizing symptom indicators and the overall latent prenatal distress means computed for US and Dutch samples, with an estimated large effect size for the latter after controlling for covariates. LIMITATIONS: Despite their relatively large sizes, our samples were limited in their representativeness of the two cultures and mechanisms contributing to observed differences were not examined. CONCLUSIONS: Pregnant women in the US reported higher levels of depression and anxiety symptoms than women in the Netherlands. Implications concern perinatal policy and clinical services (e.g., emotional health support provided to mothers).

Effectiveness of skin-to-skin contact versus care-as-usual in mothers and their full-term infants: study protocol for a parallel-group randomized controlled trial.

BACKGROUND: Twenty-to-forty percent of women experience postpartum depressive symptoms, which can affect both the mother and infant. In preterm infants, daily skin-to-skin contact (SSC) between the mother and her infant has been shown to decrease maternal postpartum depressive symptoms. In full-term infants, only two studies investigated SSC effects on maternal depressive symptoms and found similar results. Research in preterm infants also showed that SSC improves other mental and physical health outcomes of the mother and the infant, and improves the quality of mother-infant relationship. This randomized controlled trial will investigate the effects of a SSC intervention on maternal postpartum depressive symptoms and additional outcomes in mothers and their full-term infants. Moreover, two potential underlying mechanisms for the relation between SSC and the maternal and infant outcomes will be examined, namely maternal oxytocin concentrations and infant intestinal microbiota. METHODS/DESIGN: Design: A parallel-group randomized controlled trial. PARTICIPANTS: 116 mothers and their full-term infants. INTERVENTION: Mothers in the SSC condition will be requested to provide daily at least one continuous hour of SSC to their infant. The intervention starts immediately after birth and lasts for 5 weeks. Mothers in the control condition will not be requested to provide SSC. Maternal and infant outcomes will be measured at 2 weeks, 5 weeks, 12 weeks and 1 year after birth. PRIMARY OUTCOME: maternal postpartum depressive symptoms. Secondary maternal outcomes: mental health (anxiety, stress, traumatic stress following child birth, sleep quality), physical health (physical recovery from the delivery, health, breastfeeding, physiological stress), mother-infant relationship (mother-infant bond, quality of maternal caregiving behavior). Secondary infant outcomes: behavior (fussing and crying, sleep quality), physical health (growth and health, physiological stress), general development (regulation capacities, social-emotional capacities, language, cognitive and motor capacities). Secondary underlying mechanisms: maternal oxytocin concentrations, infant intestinal microbiota. DISCUSSION: As a simple and cost-effective intervention, SSC may benefit both the mother and her full-term infant in the short-and long-term. Additionally, if SSC is shown to be effective in low-risk mother-infant dyads, then thought could be given to developing programs in high-risk samples and using SSC in a preventive manner. TRIAL REGISTRATION: NTR5697 ; Registered on March 13, 2016.

Bioadhesive, rheological, lubricant and other aspects of an oral gel formulation intended for the treatment of xerostomia.

Xerostomia is commonly known as 'dry mouth' and is characterised by a reduction or loss in salivary production. A bioadhesive gel for its localised treatment was formulated to help enhance the residence time of the product, based on the polymer Carbopol 974P. The bioadhesion of various formulations was evaluated on different mucosal substrates, as simulations of the oral mucosa of xerostomic patients. Depending on the type of model substrate used, the mechanism of bioadhesion could alter. When the rheology of various formulations was examined, changes in bioadhesion were more easily interpreted, as the presence of other excipients caused an alteration in the rheological profile, with a change from a fully expanded and partially cross-linked system to an entangled system. Improving the lubricity of the product was considered important, with optimum incorporation of vegetable oil causing a desirable lowering of the observed friction of the product. The final complex formulation developed also contained salivary levels of electrolytes to help remineralisation of teeth, fluoride to prevent caries, zinc to enhance taste sensation, triclosan as the main anti-microbial/anti-inflammatory agent and non-cariogenic sweeteners with lemon flavour to increase the palatability of the product while stimulating any residual salivary function.

Formulation and preliminary in vivo dog studies of a novel drug delivery system for the treatment of periodontitis.

A novel drug delivery system for the treatment of periodontitis was developed using two components. The first was tetracycline base loaded into the microtubular excipient halloysite, which was coated with chitosan to further retard drug release. Encapsulation efficiencies of 32.5% were achieved with the loading procedure, with tetracycline base showing in vitro release for up to 50 days in simulated gingival crevicular fluid. The second component developed was a vehicle for the drug loaded coated halloysite, which was primarily based on the thermoresponsive polymer, poloxamer 407. A concentration of 20% was chosen with the thermoresponsivity of the system modified using PEG 20,000 so that the mobile product at room temperature would gel by temperature rise following syringing into a periodontal pocket. Retention of the overall system in the pocket was further improved by the addition of octyl cyanoacrylate (OCA). The thermoresponsivity of the poloxamer 407 system proved to be sensitive to the presence of added excipients with the levels of PEG 20,000 and OCA requiring modification in the presence of the halloysite component. A final formulation was developed which consisted of 200 mg of halloysite double loaded with tetracycline base and coated with chitosan, suspended in 1 ml of poloxamer 407 20% (w/w), PEG 20,000 0.5% (w/w), OCA 1.0% (w/w), water to 100%, adjusted to pH 4. The syringeability of this formulation at various temperatures was evaluated to ensure ease of delivery to the periodontal pocket. A stability study was performed to examine the change in thermoresponsivity over time, with the final formulation found to be stable for at least 9 months when stored at room temperature (approximately 20 degrees C). This formulation offered ease of delivery to the periodontal pocket and sustained release of the antibiotic for up to 6 weeks. The formulation had preliminary in vivo testing performed in dogs to determine levels of drug release, antimicrobial activity and retentive ability of the product. A wound pocket creation model was developed for the purposes of the trial. The product was easy to deliver to the pockets with application times of less than 1 min. Results showed the product was retained in the pocket for up to 6 weeks with effective tetracycline levels released locally over this time period, which achieved good antibacterial activity.

Antibiotic-bonded PTFE vascular grafts: the effect of silver antibiotic on bioactivity following implantation.

Use of an infection-resistant vascular prosthesis has appeal for grafting in sites of potential contamination or to replace graft segments involved in low-grade infections caused by coagulase-negative staphylococci (CNS). In this study, antibiotic retention on polytetrafluoroethylene (PTFE) grafts prepared using three antibiotic-bonding methods was compared following implantation into the arterial circulation. Ciprofloxacin or silver-ciprofloxacin was bonded to PTFE surfaces by surfactant-mediated or direct bonding methods. Antibiotic-bonded grafts of each type (n = 8) or control grafts (n = 2) were used to replace the carotid or femoral arteries of 10 dogs. Duplicate grafts segments (0.5 x 0.5 cm) were explanted at various time intervals ranging from 1 hr to 14 days later and imprinted onto culture plates of Klebsiella pneumonia. Antibiotic retention (micrograms/ml) was determined by measuring zones of inhibition and correlated with known disc concentrations of ciprofloxacin. Antibacterial bioactivity of grafts bonded with silver-antibiotic complexes was superior (P less than 0.02) to bonding of antibiotic alone at 3 and 24 hr following implantation. Ciprofloxacin retention in excess of the minimum bactericidal concentration (0.5 microgram/ml) of Staphylococcus epidermidis was demonstrated on all silver-antibiotic-bonded grafts after 14 days of implantation. At 7 and 14 days following implantation, the bioactivity of all antibiotic-bonded grafts exceeded 0.125 micrograms/ml of ciprofloxacin, the minimum inhibitory concentration of S. epidermidis. Bonding of silver-ciprofloxacin on PTFE grafts provided an effective source of local antibiotic release at levels which may be useful for bypass grafting in contaminated wounds or for in situ replacement of grafts infected by CNS.