Are Parents of Preschool Children Inclined to Give Consent for Participation in Nutritional Clinical Trials?

<div><p>Objective</p><p>Micronutrient deficiencies can lead to anemia, growth restriction, and poor motor and cognitive development. A clinical trial was planned to assess the impact of nutritional supplementation on cognitive measures in preschool children. Conducting clinical trials in children is difficult due to underlying laws, hesitation of the research community, and difficult enrollment. We carried out a questionnaire-based feasibility survey to assess the interest of parents towards participation in such a nutrition-based study.</p><p>Methods</p><p>After approval from the Institutional Human Research Ethics Committee, the principals of four kindergarten schools at Vallabh Vidyanagar, Anand, Gujarat, India consented to participate. Children at the participating schools were distributed a consent form and pre-tested questionnaire, to be taken home for parents to sign, fill and return.</p><p>Results</p><p>Out of a total of 1049 consent forms and questionnaires distributed, 602 (57.39%) signed and filled forms were returned. Despite fair awareness regarding the need of research, parents’ willingness to involve their children in a 6 month duration research study, not requiring invasive measures like blood pricks, was 180 (29.9%). Nearly half (250, 41.5%) did not respond and more than a quarter (172, 28.6%) declined participation on behalf of their children.</p><p>Conclusion</p><p>The interest level of a pre-school child's parents for participation of the child in a nutrition intervention study evaluating cognitive measures like memory is low. Understanding the study population’s motivating and inhibiting factors leading to decreased participation in clinical trials is necessary to facilitate the creation of a pertinent evidence base.</p></div

Interest of parents regarding participation of their children in nutrition-based research (n = 602).

<p>Interest of parents regarding participation of their children in nutrition-based research (n = 602).</p

Missed Opportunities for Sedation and Pain Management at a Level III Neonatal Intensive Care Unit, India

Background:Neonates in the neonatal intensive care unit (NICU) undergo a multitude of painful and stressful procedures during the first days of life. Stress from this pain can lead to neurodevelopmental problems that manifest in later childhood and should be prevented.Objective:To determine the number of painful procedures performed per day for each neonate, to verify documentation of painful procedures performed, and to, subsequently, note missed opportunities for providing pain relief to neonates.Methods:We conducted a cross-sectional study at a level III NICUlocated in a rural part of western India. A total of 69 neonates admitted for more than 24 hours were included.Twenty-nine neonates were directly observedfor a total of 24 hours each, and another 40 neonatal records were retrospectively reviewed for the neonate’s first 7 days of admission. All stressful and painful procedures performed on the neonate were recorded.Also recorded were any pharmaceutical pain relief agents or central nervous system depressants administered to the neonate before or at the time of the procedures. Averagenurse: patient ratio was also calculated. Data was analyzed using descriptive statistics.Results: A documentation deficit of 2.2% was observed. The average nurse: patient ratio was 1.53:1. A total of 13711 procedures were recorded, yielding 44.1 (38.1 stressful, 3.8 mildly painful and 2.2 moderately painful) procedures per patient-day. Common stressful procedures were position changing (2501) and temperature recording (2208). Common mildly and moderately painful procedures were heel prick (757) and endotracheal suctioning (526) respectively. Use of pharmacological agents coincided with 33.48% of the procedures. The choice of drug and time of administration were inappropriate, indicating that the pharmacological agents were intended not for pain relief but rather for a coexisting pathology or as sedation from ventilation with no analgesia.Conclusion: Stressful procedures are common in the NICU;mildly and moderately painful procedures fairly common. Almost two-thirds of the times, no pharmaceutical pain relief methods were used, and when administered, the pharmaceutical agentswere seldom intended for pain relief; this implies poor pain management practices and emphasizes the imperative need for educating NICU nurses, residents, fellows and attendings

Skin-to-Skin Care by Mother vs. Father for Preterm Neonatal Pain: A Randomized Control Trial (ENVIRON Trial)

Objective. To compare skin-to-skin care (SSC) given by mother and father for preterm neonatal pain control by premature infant pain profile (PIPP) score. Methods. 64 stable preterm (28-36 weeks gestational age) neonates born at a level-3 neonatal intensive care unit were included in the trial. Random allocation with the help of a computer-generated sequence was done. In group A, SSC was given by the mother 15 minutes before the first heel-stick, and subsequently, SSC was given by the father before the second heel-stick. In group B, the sequence of SSC provider was reversed. Blinded PIPP score assessment at 0, 1, and 5 minutes of heel-stick were done by two independent assessors using video recording. Results. The mean (SD) birth weight was 1665.18 (339.35) grams, and mean (SD) gestational age was 34.28 (2.24) weeks. The PIPP score at 0, 1, and 5 minutes had no statistical or clinically significant differences between both groups (PIPP score mean (SD) at 0 minute=3.20 (1.11) vs. 3.01 (1.29), p value = 0.38; 1 minute=8.59 (4.27) vs. 8.26 (4.08), p value = 0.66; 5 minutes=3.79 (1.40) vs. 3.93 (1.99), p value = 0.65 in SSC by mother and father group, respectively). Furthermore, there was no statistical difference between the groups for any components of the PIPP score (all p values > 0.05). The PIPP score at 5 minutes almost attained the 0-minute level in both the groups. Conclusion. Father is as effective as the mother for providing skin-to-skin care for preterm neonatal pain control. This trial is registered with CTRI/2018/01/016783

“Self-development matters” - Perception of Sakhis (CHWs) assessing self-development outcomes of their participation in the HBNC Program

Abstract Background Community Health Workers (CHWs) play an instrumental role in promoting socio-behavioural change at the community level, which results in changed indicators of community health. While outcomes are mostly reviewed for achieving program objectives, it is pertinent to understand the process of program implementation mainly from the perception of participating CHWs. Methods A qualitative study to understand the perception of Sakhi’s (CHWs) regarding the outcomes of their participation in Home-Based Neonatal Care (HBNC) Program implemented by a non-governmental organization (NGO). Data consisted of 3 FGDs and 20 in-depth unstructured interviews with participating Sakhis. Results Sakhis perceived their ability to take decisions at critical phases of the program as an important factor influencing their performance. The opportunity to participate as a Sakhi in the health programme initiated a process of change at the personal level. The changes perceived by Sakhis were enhancement in knowledge, skills and capabilities of Sakhis. The combination of improved skills, knowledge and attitude had culminated in the process of experiencing self-empowerment for the participating Sakhis. Their ability to positively influence the individuals and community with their initiatives to improve women and child health and save lives in critical situations facilitated development of a new identity and improved societal status in their communities. Changed power-relations at the family and community level promoted the involvement of Sakhis in the broader development agenda. Sakhis’ ability to strategize goals, evaluate their own abilities, their willingness to upgrade knowledge and take others along in bringing social change, was an evident movement towards self-development. Conclusion An opportunity for local women to participate in development programs creates potential for self-development as a cascading effect in addition to the accomplishment of planned program objective

Surmounting difficulties to provide home based neonatal care – reflections of community health workers

Abstract Background In India, community health workers’ (CHW) effectiveness in providing home-based neonatal care (HBNC) has been well documented. The nature of challenges faced and strategies adopted while providing HBNC services need to be studied in-depth. Methods A qualitative study to understand the challenges faced and strategies used by Sakhis (women CHW) while providing services as part of a HBNC program implemented by a non-profit organization. Data consisted of 20 in-depth interviews and three focus group discussions (FGD) with Sakhis. Results Sakhis negotiated with the community to start working as a CHW. They faced challenges while changing behaviors at individual level and also while bringing about a change in harmful normative practices that increased chances of maternal and neonatal mortality. Managing crises at the time of deliveries and facilitating a safe delivery was the most critical challenge faced by many Sakhis. The key strategies used by Sakhis included: proactively and persistently providing services even when they faced resistance from the woman or her family; evolving contextually suitable counseling techniques and tactics to bring about behavioral change; balancing compliance to traditional practices and promoting HBNC; defying traditional practices and assisting the woman in times of an emergency to save lives. Having on-call support from supervisors and cultivating a good working relationship with health providers facilitated effective service provision by Sakhis. Conclusion CHWs having a strong sense of commitment can develop strategies to address challenges and provide HBNC services effectively if they also have strong supervisory support