Clinical trial NCT03316547: Supporting and Enhancing NICU Sensory Experiences (SENSE)
Official title: Supporting and Enhancing NICU Sensory Experiences to Optimize Developmental Outcomes in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Birth of Newborn
Keywords: preterm
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Southern California
First posted: 2017-10-20
Enrollment: 70
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SENSE program-treatment; standard-of-care-control
Primary purpose: TREATMENT

Brief summary: Seventy preterm infants born less than or equal to 32 weeks gestation were put into either the sensory-based intervention (experiment) group or traditional care (control) group. Consecutive admissions at St. Louis Children's Hospital (SLCH) who were hospitalized in a private NICU room were recruited. The parents of infants in the sensory-based intervention group were educated and supported by trained therapists to give different positive sensory experiences to their infants while hospitalized. The traditional care group received normal, standard care while hospitalized. For both care groups, infant neurobehavior, sensory processing, and parent mental health were measured at term age prior to hospital discharge. Child development, sensory processing, and parent mental health were measured again at age one year (corrected). Differences between the two groups were explored.

Detailed description: Approximately 12%, or 500,000 infants, are born preterm each year in the United States alone. Although survival rates of preterm infants have increased with advances in medical care, the risk of developmental delay and disability has remained constant. Very preterm infants (\<32 weeks gestation) necessitate care in the neonatal intensive care unit (NICU) for an average of three months after birth, which is a significant period of time coinciding with a critical window of brain development. While medical factors, such as brain injury, can heighten the risk of adverse neurodevelopmental outcome, the NICU environment may also have deleterious effects on early brain structure and function.

The Influence of Early Environment: Maternal deprivation and isolation from positive sensory experiences are prominent features of orphan studies. Consequences of language and human deprivation include emotional disturbances, delayed cognitive and language skills, and abnormalities evident on magnetic resonance imaging (MRI). Although the preterm infant differs from a child who has been institutionalized or deprived of caregiving attention after full term birth, there are similarities, such as the altered temporal lobe structures, and the pattern of developmental impairments. There is growing evidence supporting the importance of parents in the NICU. Low frequency visits between parents and their hospitalized preterm infants have been associated with suboptimal outcomes, like child abuse and abandonment and adverse emotional functioning. NICU's in Sweden have been successful with engaging parents in care from admission to discharge and have reported shorter hospitalizations. There is also a growing body of evidence supporting positive sensory exposures for preterm infants, including maternal voice recordings, massage, skin-to-skin holding, and vestibular and kinesthetic interventions. In addition, my team has made important research findings pointing to the potential need for developmentally-appropriate sensory exposures in the NICU.

Outcomes Associated with Preterm Birth: While advances in medical technologies have improved the rates of survival among preterm infants, the risk of long-term morbidities remains high, with 50-70% of very preterm infants exhibiting developmental problems. In addition to motor problems, language and communication problems are common in former preterm infants when studied at school age, and recent evidence suggests that language deficits persist through childhood. Language difficulties have also been shown to affect a broad range of factors important for social prowess and academic achievement. In addition, preterm infants have a heightened risk of attachment disorders and other social-emotional problems.

Outcomes Associated with Parenting a Preterm Infant: Many negative psychological sequelae are associated with parenting a preterm infant, including depression, anxiety, and post-traumatic stress. Such negative parental mental health outcomes proceed to influence the parent-child relationship, leading to a parent's inability to recognize infant cues as well as increased negativity and intrusiveness. Negative maternal-child interactions continue into the first several months of life if stress remains high. Forming such a foundation may then lead to negative child outcomes associated with social-emotional development, including attachment insecurity, and mental health issues.

Sensory Stimuli and Current Practice in the NICU: High-risk infants who receive care in the NICU are exposed to significant stressors that include painful procedures, disruption of normal sensory experiences, and stress related to parent-infant separation. In addition to the loss of parental nurturing, there is growing concern that stress during a period of extensive brain development may result in permanent and deleterious developmental outcomes.

Developmental care, which includes sensory minimization, has been the predominant model of care in the NICU since the 1980s, because the bright and noisy environment, which exceeds sensory standards set by the American Academy of Pediatrics, is understood to adversely affect growth and development of the preterm infant. In support of developmental care principles, NICU staff makes efforts to reduce modifiable stimuli to the high-risk infant in the NICU. However, there is emerging research on the positive effects of sensory stimulation for preterm infants in the NICU.

Positive sensory exposures in the NICU are critical, as they can have life-long implications on learning, memory, emotions, and developmental progression. In an environment where stimuli are primarily negative, it is especially important to define and implement positive sensory exposures in the NICU. Further, it is well understood that multi-dimensional sensory exposures are present in utero in the final months and weeks of pregnancy, but the preterm infant misses potentially important, timed exposures that may be absent or altered in the NICU environment. Positive forms of sensory exposure during periods of infant readiness may be important to facilitate appropriate neural pathways and enable positive experiences.

Results from a rigorous systematic review, benchmarking, and expert opinion were used to develop a clinical practice guideline for sensory-based interventions for hospitalized, very preterm infants using the Appraisal of Guidelines for Research and Evaluation II instrument. The manualized intervention (from the integrative review and development of the implementation plan) includes evidenced-based interventions that can be conducted by parents with their preterm infants across postmenstrual age while hospitalized. The sensory-based intervention includes the provision of specific amounts of auditory, tactile, vestibular, kinesthetic, olfactory, and visual exposure to be conducted daily through hospitalization. The intervention plan is intended to be implemented by parents (when available) and by surrogates when the parents are unable to be present in the hospital. Surveys, focus groups of a multidisciplinary team of health care professionals and parents of preterm infants in the NICU, and a pilot/feasibility study were conducted to assess acceptability, appropriateness and feasibility of the sensory-based intervention plan. The investigators enrolled 30 very preterm infants within the first week of life and implemented the sensory-based program. Logging sheets were placed at the infant's bedside to document the execution of sensory-based interventions, who conducted the intervention (parent, member of research team or other caregiver), and infant responses and consequences of the intervention. Physiological (such as heart rate and oxygen saturation fluctuations), state (levels of arousal) and behavioral (such as crying, changes in motoric tone) responses were recorded by caregivers during interventions on the bedside logs. Negative sequelae of the intervention resulted in stopping the intervention and modifying the criteria for sensory-based interventions accordingly. A licensed therapist provided guidance as to when infants can and cannot tolerate sensory exposures. From clinical documentation and bedside logging, implementation factors were assessed. Adaptations to the sensory-based program were made until it was deemed appropriate by the investigative team. This occurred after the model for an enhanced sensory environment could be documented 75% of the time on at least 3 consecutive participants.

The aim of this randomized clinical trial was to assess the effect of a sensory-based intervention in the NICU on outcomes of preterm infants and their families.

After obtaining informed consent, 70 preterm infants were randomized to 2 levels of sensory exposure: the sensory-based intervention or traditional care group. The parents of infants in the sensory-based intervention group were educated and supported to conduct sensory interventions with their infants using the systematized protocol. The traditional care group had therapists and nurses provide and educate parents about sensory exposures as standard of care. For both care groups, infant neurobehavior, sensory processing, mother-infant interaction, and parent mental health were assessed at term age prior to hospital discharge. Child development, sensory processing, and parent mental health were measured again at age one year corrected using standardized measures. Differences between groups were explored.

Eligibility criteria: Inclusion Criteria:

Preterm Infants:

* A prospective cohort very preterm infants (VPT) born less than or equal to 32 weeks gestation at the St. Louis Children's Hospital in St. Louis, Missouri.
* Infant is less than or equal to 7 days old when approached about the study.

Parents:

-Parents (including emancipated minors age 12-17) of very preterm infants (VPT) born less than or equal to 32 weeks gestation at the St. Louis Children's Hospital in St. Louis, Missouri.

Exclusion Criteria:

Preterm Infants:

* Known or suspected congenital anomaly, congenital infection (e.g., syphilis, HIV, TORCH), or known prenatal brain lesions (e.g., cysts or infarctions)
* Infants that are wards of the state, or become wards of the state after enrolling in the study. Any data collected beginning at the time the state obtains custody onward will not be used in the research study.
* Infants who are in the open ward area/bed spaces of the SLCH NICU (due to the significant variation in sensory exposure among those infants, and also to provide consistency during the hospital's impending transition to strictly private rooms in the very near future).

Parents:

-Parents with limited or no understanding of the English Language

Primary outcomes:
measure: Ages and Stages Questionnaire (ASQ) - Communication at 1 Year
timeFrame: One year corrected age
measure: Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) Excitability Score at Term Equivalent Age
timeFrame: At term equivalent age (35-41 weeks PMA)
Secondary outcomes:
measure: Language Environmental Acquisition Device (LENA)
timeFrame: Single 16 hour period to capture language and sound exposure will occur at 34 weeks to assess treatment fidelity/differentiation.
measure: Sensory Exposures Provided During Hospitalization
timeFrame: Sensory exposures were documented every day of hospitalization (from birth to term-equivalent age; an average of about 2 months).
measure: Dubowitz/Hammersmith Neonatal Neurological Evaluation
timeFrame: At term equivalent age (between 35-41 weeks post menstrual age), just prior to discharge from the hospital.
measure: General Movement Assessment (GMA)
timeFrame: At term equivalent age (between 35-41 weeks post menstrual age), just prior to discharge from the hospital.
measure: Discharge Questionnaire
timeFrame: Just prior to discharge from the hospital (between 35-41 weeks post menstrual age).
measure: 1 Year Follow-Up Questionnaire
timeFrame: One year corrected age.
measure: Mother-Infant Interaction (at 1 Year Follow-up)
timeFrame: One year corrected age.
measure: Parent Engagement During Hospitalization
timeFrame: Every day of hospitalization (from birth through discharge, often close to term equivalent age; on average about 2 months).
measure: Language Environmental Acquisition Device (LENA) Adult Word Count
timeFrame: Single 16 hour period to capture language and sound exposure will occur at 34 weeks to assess treatment fidelity/differentiation.
measure: Percentage of Sensory Interventions Received
timeFrame: Sensory exposures were documented every day of hospitalization (birth through discharge, often close to term) equivalent age).
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine; University of Southern California
name: Roberta G Pineda, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
citation: Volpe, J., Neurology of the Newborn 2008, Saunders: Philadelphia.
citation: Seay B, Harlow HF. Maternal separation in the rhesus monkey. J Nerv Ment Dis. 1965 Jun;140(6):434-41. doi: 10.1097/00005053-196506000-00006. No abstract available.
citation: Tottenham N, Hare TA, Quinn BT, McCarry TW, Nurse M, Gilhooly T, Millner A, Galvan A, Davidson MC, Eigsti IM, Thomas KM, Freed PJ, Booma ES, Gunnar MR, Altemus M, Aronson J, Casey BJ. Prolonged institutional rearing is associated with atypically large amygdala volume and difficulties in emotion regulation. Dev Sci. 2010 Jan 1;13(1):46-61. doi: 10.1111/j.1467-7687.2009.00852.x.
citation: Tottenham N, Sheridan MA. A review of adversity, the amygdala and the hippocampus: a consideration of developmental timing. Front Hum Neurosci. 2010 Jan 8;3:68. doi: 10.3389/neuro.09.068.2009. eCollection 2009.
citation: BRODBECK AJ, IRWIN OC. The speech behaviour of infants without families. Child Dev. 1946 Sep;17(3):145-56. No abstract available.
citation: Govindan RM, Behen ME, Helder E, Makki MI, Chugani HT. Altered water diffusivity in cortical association tracts in children with early deprivation identified with Tract-Based Spatial Statistics (TBSS). Cereb Cortex. 2010 Mar;20(3):561-9. doi: 10.1093/cercor/bhp122. Epub 2009 Jun 22.
citation: Aeby A, Van Bogaert P, David P, Baleriaux D, Vermeylen D, Metens T, De Tiege X. Nonlinear microstructural changes in the right superior temporal sulcus and lateral occipitotemporal gyrus between 35 and 43 weeks in the preterm brain. Neuroimage. 2012 Oct 15;63(1):104-10. doi: 10.1016/j.neuroimage.2012.06.013. Epub 2012 Jun 17.
citation: Barre N, Morgan A, Doyle LW, Anderson PJ. Language abilities in children who were very preterm and/or very low birth weight: a meta-analysis. J Pediatr. 2011 May;158(5):766-774.e1. doi: 10.1016/j.jpeds.2010.10.032. Epub 2010 Dec 10.
citation: Reynolds LC, Duncan MM, Smith GC, Mathur A, Neil J, Inder T, Pineda RG. Parental presence and holding in the neonatal intensive care unit and associations with early neurobehavior. J Perinatol. 2013 Aug;33(8):636-41. doi: 10.1038/jp.2013.4. Epub 2013 Feb 14.
citation: Fanaroff AA, Kennell JH, Klaus MH. Follow-up of low birth weight infants--the predictive value of maternal visiting patterns. Pediatrics. 1972 Feb;49(2):287-90. No abstract available.
citation: Latva R, Lehtonen L, Salmelin RK, Tamminen T. Visiting less than every day: a marker for later behavioral problems in Finnish preterm infants. Arch Pediatr Adolesc Med. 2004 Dec;158(12):1153-7. doi: 10.1001/archpedi.158.12.1153.
citation: Ortenstrand A, Westrup B, Brostrom EB, Sarman I, Akerstrom S, Brune T, Lindberg L, Waldenstrom U. The Stockholm Neonatal Family Centered Care Study: effects on length of stay and infant morbidity. Pediatrics. 2010 Feb;125(2):e278-85. doi: 10.1542/peds.2009-1511. Epub 2010 Jan 25.
citation: Krueger C, Parker L, Chiu SH, Theriaque D. Maternal voice and short-term outcomes in preterm infants. Dev Psychobiol. 2010 Mar;52(2):205-12. doi: 10.1002/dev.20426.
citation: Diego MA, Field T, Hernandez-Reif M. Preterm infant weight gain is increased by massage therapy and exercise via different underlying mechanisms. Early Hum Dev. 2014 Mar;90(3):137-40. doi: 10.1016/j.earlhumdev.2014.01.009. Epub 2014 Jan 27.
citation: Hernandez-Reif M, Diego M, Field T. Preterm infants show reduced stress behaviors and activity after 5 days of massage therapy. Infant Behav Dev. 2007 Dec;30(4):557-61. doi: 10.1016/j.infbeh.2007.04.002. Epub 2007 Jun 4.
citation: Mendes EW, Procianoy RS. Massage therapy reduces hospital stay and occurrence of late-onset sepsis in very preterm neonates. J Perinatol. 2008 Dec;28(12):815-20. doi: 10.1038/jp.2008.108. Epub 2008 Jul 17.
citation: Feldman R, Rosenthal Z, Eidelman AI. Maternal-preterm skin-to-skin contact enhances child physiologic organization and cognitive control across the first 10 years of life. Biol Psychiatry. 2014 Jan 1;75(1):56-64. doi: 10.1016/j.biopsych.2013.08.012. Epub 2013 Oct 4.
citation: Scher MS, Ludington-Hoe S, Kaffashi F, Johnson MW, Holditch-Davis D, Loparo KA. Neurophysiologic assessment of brain maturation after an 8-week trial of skin-to-skin contact on preterm infants. Clin Neurophysiol. 2009 Oct;120(10):1812-8. doi: 10.1016/j.clinph.2009.08.004. Epub 2009 Sep 17.
citation: White-Traut RC, Nelson MN, Silvestri JM, Vasan U, Littau S, Meleedy-Rey P, Gu G, Patel M. Effect of auditory, tactile, visual, and vestibular intervention on length of stay, alertness, and feeding progression in preterm infants. Dev Med Child Neurol. 2002 Feb;44(2):91-7. doi: 10.1017/s0012162201001736.
citation: Vignochi CM, Silveira RC, Miura E, Canani LH, Procianoy RS. Physical therapy reduces bone resorption and increases bone formation in preterm infants. Am J Perinatol. 2012 Sep;29(8):573-8. doi: 10.1055/s-0032-1310520. Epub 2012 Jul 6.
citation: Maguire CM, Walther FJ, van Zwieten PH, Le Cessie S, Wit JM, Veen S. Follow-up outcomes at 1 and 2 years of infants born less than 32 weeks after Newborn Individualized Developmental Care and Assessment Program. Pediatrics. 2009 Apr;123(4):1081-7. doi: 10.1542/peds.2008-1950.
citation: Reproductive Health, Preterm Birth. March 23, 2012; Available from: http://www.cdc.gov/reproductivehealth/maternalinfanthealth/PretermBirth.htm.
citation: Williams J, Lee KJ, Anderson PJ. Prevalence of motor-skill impairment in preterm children who do not develop cerebral palsy: a systematic review. Dev Med Child Neurol. 2010 Mar;52(3):232-7. doi: 10.1111/j.1469-8749.2009.03544.x. Epub 2010 Feb 4.
citation: Botting, N., Z. Simkin, and G. Conti-Ramsden, Associated reading skills in children with a history of Specific Language Impairment (SLI). Read Writ, 2006. 19: p. 77-98.
citation: Durkin K, Conti-Ramsden G. Language, social behavior, and the quality of friendships in adolescents with and without a history of specific language impairment. Child Dev. 2007 Sep-Oct;78(5):1441-57. doi: 10.1111/j.1467-8624.2007.01076.x.
citation: Mulder H, Pitchford NJ, Hagger MS, Marlow N. Development of executive function and attention in preterm children: a systematic review. Dev Neuropsychol. 2009;34(4):393-421. doi: 10.1080/87565640902964524.
citation: Pedespan L. [Attachment and prematurity]. Gynecol Obstet Fertil. 2004 Sep;32(9):716-20. doi: 10.1016/j.gyobfe.2004.06.016. French.
citation: Quesada AA, Tristao RM, Pratesi R, Wolf OT. Hyper-responsiveness to acute stress, emotional problems and poorer memory in former preterm children. Stress. 2014 Sep;17(5):389-99. doi: 10.3109/10253890.2014.949667.
citation: Miles MS, Holditch-Davis D, Schwartz TA, Scher M. Depressive symptoms in mothers of prematurely born infants. J Dev Behav Pediatr. 2007 Feb;28(1):36-44. doi: 10.1097/01.DBP.0000257517.52459.7a.
citation: Zelkowitz P, Na S, Wang T, Bardin C, Papageorgiou A. Early maternal anxiety predicts cognitive and behavioural outcomes of VLBW children at 24 months corrected age. Acta Paediatr. 2011 May;100(5):700-4. doi: 10.1111/j.1651-2227.2010.02128.x. Epub 2011 Jan 11.
citation: Holditch-Davis D, Bartlett TR, Blickman AL, Miles MS. Posttraumatic stress symptoms in mothers of premature infants. J Obstet Gynecol Neonatal Nurs. 2003 Mar-Apr;32(2):161-71. doi: 10.1177/0884217503252035.
citation: O'Hara MW, McCabe JE. Postpartum depression: current status and future directions. Annu Rev Clin Psychol. 2013;9:379-407. doi: 10.1146/annurev-clinpsy-050212-185612. Epub 2013 Feb 1.
citation: Spinelli M, Poehlmann J, Bolt D. Predictors of parenting stress trajectories in premature infant-mother dyads. J Fam Psychol. 2013 Dec;27(6):873-83. doi: 10.1037/a0034652. Epub 2013 Nov 4.
citation: Shah PE, Clements M, Poehlmann J. Maternal resolution of grief after preterm birth: implications for infant attachment security. Pediatrics. 2011 Feb;127(2):284-92. doi: 10.1542/peds.2010-1080. Epub 2011 Jan 17.
citation: Woodward LJ, Bora S, Clark CA, Montgomery-Honger A, Pritchard VE, Spencer C, Austin NC. Very preterm birth: maternal experiences of the neonatal intensive care environment. J Perinatol. 2014 Jul;34(7):555-61. doi: 10.1038/jp.2014.43. Epub 2014 Mar 20.
citation: Gray RF, Indurkhya A, McCormick MC. Prevalence, stability, and predictors of clinically significant behavior problems in low birth weight children at 3, 5, and 8 years of age. Pediatrics. 2004 Sep;114(3):736-43. doi: 10.1542/peds.2003-1150-L.
citation: Nomura Y, Wickramaratne PJ, Warner V, Mufson L, Weissman MM. Family discord, parental depression, and psychopathology in offspring: ten-year follow-up. J Am Acad Child Adolesc Psychiatry. 2002 Apr;41(4):402-9. doi: 10.1097/00004583-200204000-00012.
citation: Smith GC, Gutovich J, Smyser C, Pineda R, Newnham C, Tjoeng TH, Vavasseur C, Wallendorf M, Neil J, Inder T. Neonatal intensive care unit stress is associated with brain development in preterm infants. Ann Neurol. 2011 Oct;70(4):541-9. doi: 10.1002/ana.22545. Epub 2011 Oct 4.
citation: Douret, L., M. Robin, and M. Le Normandy, The history of care of premature infants: from neonate intensive care to special care baby unit. Early Child Dev Care, 1994. 182: p. 21-29.
citation: Noise: a hazard for the fetus and newborn. American Academy of Pediatrics. Committee on Environmental Health. Pediatrics. 1997 Oct;100(4):724-7. No abstract available.
citation: Brandon DH, Holditch-Davis D, Belyea M. Preterm infants born at less than 31 weeks' gestation have improved growth in cycled light compared with continuous near darkness. J Pediatr. 2002 Feb;140(2):192-9. doi: 10.1067/mpd.2002.121932.
citation: Field T. Alleviating stress in newborn infants in the intensive care unit. Clin Perinatol. 1990 Mar;17(1):1-9.
citation: Graven SN, Bowen FW Jr, Brooten D, Eaton A, Graven MN, Hack M, Hall LA, Hansen N, Hurt H, Kavalhuna R, et al. The high-risk infant environment. Part 1. The role of the neonatal intensive care unit in the outcome of high-risk infants. J Perinatol. 1992 Jun;12(2):164-72. No abstract available.
citation: Byers JF. Components of developmental care and the evidence for their use in the NICU. MCN Am J Matern Child Nurs. 2003 May-Jun;28(3):174-80; quiz 181-2. doi: 10.1097/00005721-200305000-00007.
citation: Lasky RE, Williams AL. Noise and light exposures for extremely low birth weight newborns during their stay in the neonatal intensive care unit. Pediatrics. 2009 Feb;123(2):540-6. doi: 10.1542/peds.2007-3418.
citation: Lickliter R. The integrated development of sensory organization. Clin Perinatol. 2011 Dec;38(4):591-603. doi: 10.1016/j.clp.2011.08.007. Epub 2011 Oct 13.
citation: Hepper PG, Shahidullah BS. Development of fetal hearing. Arch Dis Child Fetal Neonatal Ed. 1994 Sep;71(2):F81-7. doi: 10.1136/fn.71.2.f81.
citation: Pineda RG, Stransky KE, Rogers C, Duncan MH, Smith GC, Neil J, Inder T. The single-patient room in the NICU: maternal and family effects. J Perinatol. 2012 Jul;32(7):545-51. doi: 10.1038/jp.2011.144. Epub 2011 Oct 27.
citation: Pineda, R., Neil, J., Dierker, D., Smyser, C., Kidokora, H., Reynolds, L., Walker, S., Rogers, C., Mathur, A., VanEssen, D., Inder, T., The Impact of Different Neonatal Intensive Care Environments on Brain Development and Function in Preterm Infants, 2012, Washington University School of Medicine.
citation: Caskey, M., Tucker, R., Vohr. Language environment in a single familly room NICU. in Pediatric Academic Societies. 2012. Boston, MA.
citation: Liu WF. Comparing sound measurements in the single-family room with open-unit design neonatal intensive care unit: the impact of equipment noise. J Perinatol. 2012 May;32(5):368-73. doi: 10.1038/jp.2011.103. Epub 2011 Aug 18.
citation: Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers B, Graham ID, Grimshaw J, Hanna SE, Littlejohns P, Makarski J, Zitzelsberger L; AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. J Clin Epidemiol. 2010 Dec;63(12):1308-11. doi: 10.1016/j.jclinepi.2010.07.001. Epub 2010 Jul 24. No abstract available.
citation: Pineda JA, Leonard JR, Mazotas IG, Noetzel M, Limbrick DD, Keller MS, Gill J, Doctor A. Effect of implementation of a paediatric neurocritical care programme on outcomes after severe traumatic brain injury: a retrospective cohort study. Lancet Neurol. 2013 Jan;12(1):45-52. doi: 10.1016/S1474-4422(12)70269-7. Epub 2012 Nov 28.
citation: Proctor EK, Powell BJ, Baumann AA, Hamilton AM, Santens RL. Writing implementation research grant proposals: ten key ingredients. Implement Sci. 2012 Oct 12;7:96. doi: 10.1186/1748-5908-7-96.
citation: Proctor E. Implementation science and child maltreatment: methodological advances. Child Maltreat. 2012 Feb;17(1):107-12. doi: 10.1177/1077559512437034. Epub 2012 Feb 15. No abstract available.
citation: Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.
citation: Proctor EK, Landsverk J, Aarons G, Chambers D, Glisson C, Mittman B. Implementation research in mental health services: an emerging science with conceptual, methodological, and training challenges. Adm Policy Ment Health. 2009 Jan;36(1):24-34. doi: 10.1007/s10488-008-0197-4. Epub 2008 Dec 23.
citation: Proctor EK, Rosen A. From Knowledge Production to Implementation: Research Challenges and Imperatives. Res Soc Work Pract. 2008 Jul 1;18(4):285-291. doi: 10.1177/1049731507302263.
citation: Khlif MS, Colditz PB, Boashash B. Effective implementation of time-frequency matched filter with adapted pre and postprocessing for data-dependent detection of newborn seizures. Med Eng Phys. 2013 Dec;35(12):1762-9. doi: 10.1016/j.medengphy.2013.07.005. Epub 2013 Aug 21.
citation: Lobb R, Colditz GA. Implementation science and its application to population health. Annu Rev Public Health. 2013;34:235-51. doi: 10.1146/annurev-publhealth-031912-114444. Epub 2013 Jan 7.
citation: Wolin KY, Colditz GA, Proctor EK. Maximizing benefits for effective cancer survivorship programming: defining a dissemination and implementation plan. Oncologist. 2011;16(8):1189-96. doi: 10.1634/theoncologist.2011-0054. Epub 2011 Jul 17.
citation: Speilberger, C., State-Trait Anxiety Inventory for Adults. 2005-2008, Menlo Park, CA: Mind Garden.
citation: Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
citation: Endler, N., Coping Inventory for Stressful Situations (CISS): Manual. 1990, Toronto: Multi-Health Systems.
citation: Abidin, R.R., Parenting stress index professional manual. 3 ed. 1995, Odessa, FL: Psychological Assessment Resources, Inc.
citation: Tronick E, Lester BM. Grandchild of the NBAS: the NICU network neurobehavioral scale (NNNS): a review of the research using the NNNS. J Child Adolesc Psychiatr Nurs. 2013 Aug;26(3):193-203. doi: 10.1111/jcap.12042.
citation: Dunn, W., Infant/Toddler Sensory Profile 2. 2014, San Antonio: Pearson Education, Inc.
citation: Squires, J., et al., Ages and Stages Questionnaires - 3. 2009, Baltimore, MD: Paul H. Brookes Publishing Co.
citation: Beck, A.T., R.A. Steer, and G.K. Brown, Manual for the beck depression inventory-II. 1996, San Antonio, TX: Psychological Corporation.
citation: Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
citation: Snaith, R.P. and A.S. Zigmond, The hospital anxiety and depression scale manual. 1994, Windsor, Ontario: NFER-Nelson.
citation: Yu YT, Hsieh WS, Hsu CH, Chen LC, Lee WT, Chiu NC, Wu YC, Jeng SF. A psychometric study of the Bayley Scales of Infant and Toddler Development - 3rd Edition for term and preterm Taiwanese infants. Res Dev Disabil. 2013 Nov;34(11):3875-83. doi: 10.1016/j.ridd.2013.07.006. Epub 2013 Sep 9.
citation: Pineda RG, Tjoeng TH, Vavasseur C, Kidokoro H, Neil JJ, Inder T. Patterns of altered neurobehavior in preterm infants within the neonatal intensive care unit. J Pediatr. 2013 Mar;162(3):470-476.e1. doi: 10.1016/j.jpeds.2012.08.011. Epub 2012 Oct 1.
citation: Howe TH, Sheu CF, Wang TN, Hsu YW. Parenting stress in families with very low birth weight preterm infants in early infancy. Res Dev Disabil. 2014 Jul;35(7):1748-56. doi: 10.1016/j.ridd.2014.02.015. Epub 2014 Mar 19.
citation: Singer LT, Fulton S, Kirchner HL, Eisengart S, Lewis B, Short E, Min MO, Satayathum S, Kercsmar C, Baley JE. Longitudinal predictors of maternal stress and coping after very low-birth-weight birth. Arch Pediatr Adolesc Med. 2010 Jun;164(6):518-24. doi: 10.1001/archpediatrics.2010.81.
citation: Wraight CL, McCoy J, Meadow W. Beyond stress: describing the experiences of families during neonatal intensive care. Acta Paediatr. 2015 Oct;104(10):1012-7. doi: 10.1111/apa.13071. Epub 2015 Jun 26.
citation: Bouet KM, Claudio N, Ramirez V, Garcia-Fragoso L. Loss of parental role as a cause of stress in the neonatal intensive care unit. Bol Asoc Med P R. 2012 Jan-Mar;104(1):8-11.
citation: Heinemann AB, Hellstrom-Westas L, Hedberg Nyqvist K. Factors affecting parents' presence with their extremely preterm infants in a neonatal intensive care room. Acta Paediatr. 2013 Jul;102(7):695-702. doi: 10.1111/apa.12267. Epub 2013 May 8.
citation: Anderson P, Doyle LW; Victorian Infant Collaborative Study Group. Neurobehavioral outcomes of school-age children born extremely low birth weight or very preterm in the 1990s. JAMA. 2003 Jun 25;289(24):3264-72. doi: 10.1001/jama.289.24.3264.
citation: Anderson PJ, Doyle LW. Cognitive and educational deficits in children born extremely preterm. Semin Perinatol. 2008 Feb;32(1):51-8. doi: 10.1053/j.semperi.2007.12.009.
citation: Holsti L, Grunau RV, Whitfield MF. Developmental coordination disorder in extremely low birth weight children at nine years. J Dev Behav Pediatr. 2002 Feb;23(1):9-15. doi: 10.1097/00004703-200202000-00002.
citation: Goyen TA, Lui K, Woods R. Visual-motor, visual-perceptual, and fine motor outcomes in very-low-birthweight children at 5 years. Dev Med Child Neurol. 1998 Feb;40(2):76-81. doi: 10.1111/j.1469-8749.1998.tb15365.x.
citation: Pineda RG, Neil J, Dierker D, Smyser CD, Wallendorf M, Kidokoro H, Reynolds LC, Walker S, Rogers C, Mathur AM, Van Essen DC, Inder T. Alterations in brain structure and neurodevelopmental outcome in preterm infants hospitalized in different neonatal intensive care unit environments. J Pediatr. 2014 Jan;164(1):52-60.e2. doi: 10.1016/j.jpeds.2013.08.047. Epub 2013 Oct 17.
citation: Bystron I, Blakemore C, Rakic P. Development of the human cerebral cortex: Boulder Committee revisited. Nat Rev Neurosci. 2008 Feb;9(2):110-22. doi: 10.1038/nrn2252.
citation: Burns CM, Rutherford MA, Boardman JP, Cowan FM. Patterns of cerebral injury and neurodevelopmental outcomes after symptomatic neonatal hypoglycemia. Pediatrics. 2008 Jul;122(1):65-74. doi: 10.1542/peds.2007-2822.
citation: Berument SK, Sonmez D, Eyupoglu H. Supporting language and cognitive development of infants and young children living in children's homes in Turkey. Child Care Health Dev. 2012 Sep;38(5):743-52. doi: 10.1111/j.1365-2214.2011.01314.x. Epub 2011 Sep 27.
citation: Daunhauer LA, Coster WJ, Tickle-Degnen L, Cermak SA. Effects of caregiver-child interactions on play occupations among young children institutionalized in Eastern Europe. Am J Occup Ther. 2007 Jul-Aug;61(4):429-40. doi: 10.5014/ajot.61.4.429.
citation: Daunhauer LA, Coster WJ, Tickle-Degnen L, Cermak SA. Play and cognition among young children reared in an institution. Phys Occup Ther Pediatr. 2010 May;30(2):83-97. doi: 10.3109/01942630903543682.
citation: Ellis BH, Fisher PA, Zaharie S. Predictors of disruptive behavior, developmental delays, anxiety, and affective symptomatology among institutionally reared romanian children. J Am Acad Child Adolesc Psychiatry. 2004 Oct;43(10):1283-92. doi: 10.1097/01.chi.0000136562.24085.160.