Striving for Optimum Noise-Decreasing Strategies in Critical Care: Initial Measurements and Observations.

To identify baseline sound levels, patterns of sound levels, and potential barriers and facilitators to sound level reduction. The study setting was neonatal and pediatric intensive care units in a tertiary care hospital. Participants were staff in both units and parents of currently hospitalized children or infants. One 24-hour sound measurements and one 4-hour sound measurement linked to observed sound events were conducted in each area of the center's neonatal intensive care unit. Two of each measurement type were conducted in the pediatric intensive care unit. Focus groups were conducted with parents and staff. Transcripts were analyzed with descriptive content analysis and themes were compared against results from quantitative measurements. Sound levels exceeded recommended standards at nearly every time point. The most common code was related to talking. Themes from focus groups included the critical care context and sound levels, effects of sound levels, and reducing sound levels-the way forward. Results are consistent with work conducted in other critical care environments. Staff and families realize that high sound levels can be a problem, but feel that the culture and context are not supportive of a quiet care space. High levels of ambient sound suggest that the largest changes in sound levels are likely to come from design and equipment purchase decisions. L10 and Lmax appear to be the best outcomes for measurement of behavioral interventions.

Effect of cobedding twins on coregulation, infant state, and twin safety.

OBJECTIVE: To evaluate the efficacy of cobedding on twin coregulation and twin safety. DESIGN: Randomized controlled trial (RCT). SETTING: Two university affiliated Level III neonatal intensive care units (NICUs). PARTICIPANTS: One hundred and seventeen sets (N = 234) of stable preterm twins (<37 weeks gestational age at birth) admitted to the NICU. METHODS: Sets of twins were randomly assigned to be cared for in a single cot (cobedded) or in separate cots (standard care). State response was obtained from videotaped and physiologic data measured and recorded for three, 3-hour sessions over a one-week study period. Tapes were coded for infant state by an assessor blind to the purpose of the study. RESULTS: Twins who were cobedded spent more time in the same state (p < .01), less time in opposite states (p < .01), were more often in quiet sleep (p < .01) and cried less (p < .01) than twins who were cared for in separate cots. There was no difference in physiological parameters between groups (p = .85). There was no difference in patient safety between groups (incidence of sepsis, p = .95), incidence of caregiver error (p = .31), and incidence of apnea (p = .70). CONCLUSIONS: Cobedding promotes self-regulation and sleep and decreases crying without apparent increased risk.

Understanding kangaroo care and its benefits to preterm infants.

The holding of an infant with ventral skin-to-skin contact typically in an upright position with the swaddled infant on the chest of the parent, is commonly referred to as kangaroo care (KC), due to its simulation of marsupial care. It is recommended that KC, as a feasible, natural, and cost-effective intervention, should be standard of care in the delivery of quality health care for all infants, regardless of geographic location or economic status. Numerous benefits of its use have been reported related to mortality, physiological (thermoregulation, cardiorespiratory stability), behavioral (sleep, breastfeeding duration, and degree of exclusivity) domains, as an effective therapy to relieve procedural pain, and improved neurodevelopment. Yet despite these recommendations and a lack of negative research findings, adoption of KC as a routine clinical practice remains variable and underutilized. Furthermore, uncertainty remains as to whether continuous KC should be recommended in all settings or if there is a critical period of initiation, dose, or duration that is optimal. This review synthesizes current knowledge about the benefits of KC for infants born preterm, highlighting differences and similarities across low and higher resource countries and in a non-pain and pain context. Additionally, implementation considerations and unanswered questions for future research are addressed.

Co-bedding between preterm twins attenuates stress response after heel lance: results of a randomized trial.

OBJECTIVE: To examine the effect of co-bedding between preterm twins on stress response after heel lance. METHODS: Using a multisite randomized controlled trial design, stable preterm twins (67 sets, N=134 infants) between 28 and 36 completed weeks' gestational age, stratified by gestational age (≤ and >32 weeks) and site, were randomly assigned to a co-bedding group, cared for continuously in the same incubator or crib or a standard care group, cared for in a separate incubator or crib, and underwent a medically indicated heel lance after at least 24 hours and no greater than 10 days of group allocation. The reported outcome was cortisol from saliva samples from 89 twins (n=49 co-bedding, n=40 standard care) collected immediately before the heel lance (baseline levels) and 113 twins (n=58 co-bedding, n=55 standard care) collected 20 minutes after heel lance (stress levels) as an index of stress response. RESULTS: No group differences were noted in baseline salivary cortisol levels: 0.36 µg/dL (SD 0.25) in the co-bedding group and 0.43 µg/dL (SD 0.50) in the standard care group. Twenty minutes after lance, levels were significantly lower in the co-bedding group, 0.28 µg/dL (SD 0.25) versus 0.50 µg/dL (SD 0.73) in the standard group (P=0.04). Similarly, the mean of paired changes in salivary cortisol from baseline was lower in the co-bedding group (-0.06 µg/dL) compared with the standard care group (0.14 µg/dL, P<0.05). DISCUSSION: Co-bedding attenuates the stress response of preterm twins undergoing heel lance. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT009176.

Cobedding and recovery time after heel lance in preterm twins: results of a randomized trial.

OBJECTIVES: Cobedding of preterm twin infants provides tactile, olfactory, and auditory stimulation and may affect pain reactivity. We carried out a randomized trial to assess the effect of cobedding on pain reactivity and recovery in preterm twin neonates. METHODS: Stable preterm twins (n = 67 sets) between 28 and 36 weeks of gestational age were randomly assigned to a cobedding group (cared for in the same incubator or crib) or a standard care group (cared for in separate incubators or cribs). Pain response (determined by the Premature Infant Pain Profile [PIPP]) and time to return to physiologic baseline parameters were compared between groups with adjustment for the nonindependence of twin infants. RESULTS: Maternal and infant characteristics were not significantly different between twin infants in the cobedding and standard care groups except for 5-minute Apgar <7 and postnatal age and corrected gestational age on the day of the heel lance. Mean PIPP scores were not different between groups at 30, 60, or 120 seconds. At 90 seconds, mean PIPP scores were higher in the cobedding group (6.0 vs 5.0, P = .04). Recovery time was shorter in the cobedding group compared with the standard care group, (mean = 75.6 seconds versus 142.1 seconds, P = .001). No significant adverse events were associated with cobedding. Adjustment for nonindependence between twins and differences in baseline characteristics did not change the results. CONCLUSIONS: Cobedding enhanced the physiologic recovery of preterm twins undergoing heel lance, but did not lead to lower pain scores.

Effect of domperidone on the composition of preterm human breast milk.

OBJECTIVE: Domperidone is increasingly prescribed to improve breast milk volume despite a lack of evidence regarding its effects on breast milk composition. We examined the effect of domperidone on the nutrient composition of breast milk. PATIENTS AND METHODS: Forty-six mothers who had delivered infants at <31 weeks' gestation, who experienced lactation failure, were randomly assigned to receive domperidone or placebo for 14 days. Protein, energy, fat, carbohydrate, sodium, calcium, and phosphate levels in breast milk were measured on days 0, 4, 7, and 14, serum prolactin levels were measured on days 0, 4, and 14, and total milk volume was recorded daily. Mean within-subject changes in nutrients and milk volumes were examined. RESULTS: Maternal and infant characteristics, serum prolactin level, and breast milk volume and composition were not significantly different between domperidone and placebo groups on day 0. By day 14, breast milk volumes increased by 267% in the domperidone-treated group and by 18.5% in the placebo group (P = .005). Serum prolactin increased by 97% in the domperidone group and by 17% in the placebo group (P = .07). Mean breast milk protein declined by 9.6% in the domperidone group and increased by 3.6% in the placebo group (P = .16). Changes in energy, fat, carbohydrate, sodium, and phosphate content were also not significantly different between groups. Significant increases were observed in breast milk carbohydrate (2.7% vs -2.7%; P = .05) and calcium (61.8% vs -4.4%; P = .001) in the domperidone versus placebo groups. No significant adverse events were observed among mothers or infants. CONCLUSION: Domperidone increases the volume of breast milk of preterm mothers experiencing lactation failure, without substantially altering the nutrient composition.

Co-bedding as a Comfort measure For Twins undergoing painful procedures (CComForT Trial).

BACKGROUND: Co-bedding, a developmental care strategy, is the practice of caring for diaper clad twins in one incubator (versus separating and caring for each infant in separate incubators), thus creating the opportunity for skin-to-skin contact and touch between the twins. In studies of mothers and their infants, maternal skin-to-skin contact has been shown to decrease procedural pain response according to both behavioral and physiological indicators in very preterm neonates. It is uncertain if this comfort is derived solely from maternal presence or from stabilization of regulatory processes from direct skin contact. The intent of this study is to compare the comfort effect of co-bedding (between twin infants who are co-bedding and those who are not) on infant pain response and physiologic stability during a tissue breaking procedure (heelstick). METHODS/DESIGN: Medically stable preterm twin infants admitted to the Neonatal Intensive Care Unit will be randomly assigned to a co-bedding group or a standard care group. Pain response will be measured by physiological and videotaped facial reaction using the Premature Infant Pain Profile scale (PIPP). Recovery from the tissue breaking procedure will be determined by the length of time for heart rate and oxygen saturation to return to baseline. Sixty four sets of twins (n = 128) will be recruited into the study. Analysis and inference will be based on the intention-to-treat principle. DISCUSSION: If twin contact while co-bedding is determined to have a comforting effect for painful procedures, then changes in current neonatal care practices to include co-bedding may be an inexpensive, non invasive method to help maintain physiologic stability and decrease the long term psychological impact of procedural pain in this high risk population. Knowledge obtained from this study will also add to existing theoretical models with respect to the exact mechanism of comfort through touch. TRIAL REGISTRATION: NCT00917631.

Study protocol: a double blind placebo controlled trial examining the effect of domperidone on the composition of breast milk [NCT00308334].

BACKGROUND: Domperidone, a drug that enhances upper gastric motility, is an anti-dopaminergic medication that also elevates prolactin levels. It has been shown to safely increase the milk supply of lactating women. To date, researchers have analyzed the effects of domperidone on lactating woman with respect to the quantity of their milk production, adverse effects, and drug levels in the breast milk. However, the effect of domperidone on the macronutrient composition of breast milk has not been studied and current guidelines for fortification of human milk for premature infants do not distinguish between those women using or those not using domperidone. The purpose of this study is to evaluate the effect of domperidone (given to lactating mothers of very preterm infants) on the macronutrient composition of breast milk. METHODS/DESIGN: Mothers of infants delivered at less than 31 weeks gestation, who are at least 3 weeks postpartum, and experiencing lactational failure despite non-pharmacological interventions, will be randomized to receive domperidone (10 mg three times daily) or placebo for a 14-day period. Breast milk samples will be obtained the day prior to beginning treatment and on days 4, 7 and 14. The macronutrient (protein, fat, carbohydrate and energy) and macromineral content (calcium, phosphorus and sodium) will be analyzed and compared between the two groups. Additional outcome measures will include milk volumes, serum prolactin levels (measured on days 0, 4, and 10), daily infant weights and breastfeeding rates at 2 weeks post study completion and at discharge. Forty-four participants will be recruited into the study. Analysis will be carried out using the intention to treat approach. DISCUSSION: If domperidone causes significant changes to the nutrient content of breast milk, an alteration in feeding practices for preterm infants may need to be made in order to optimize growth, nutrition and neurodevelopment outcomes.