Premature Birth of Newborn Clinical Trial
— RESILIENCEOfficial title:
The Effect of Perinatal Stress on the Development of Preterm Infants
NCT number | NCT02623400 |
Other study ID # | S58807 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | October 2022 |
In this project, the investigators will study a cohort of preterm infants, together with
their parents, during NICU hospitalization and follow their developmental trajectory until
the age of two.
An important first scientific goal of the project is to identify objective stress markers
that can be obtained easily and non-invasively in preterm infants during NICU
hospitalization. This will include the development of novel techniques to measure stress
related heart rate variability (HRV) and EEG maturation, as well as sleep stage markers for
preterm infants.
Secondly, the investigators will study the emotional and bonding processes in parents of
preterm infants. Parental distress in terms of depressive symptoms, anxiety, perceived stress
and parent-infant bonding will be measured at multiple measuring points. This will enable the
validation of psychometric instruments in the specific population of parents of preterm
infants. Also, the investigators can investigate the effect and predictive value of the
course of parental depression, anxiety and stress scores on child's developmental outcome and
on parent-infant bonding and attachment.
Thirdly, studies on epigenetic changes due to prenatal stress are still scarce in humans. In
this study, the investigators will include a cohort of mothers experiencing profound prenatal
stress due to preterm labor, which will complement the earlier work that has been carried out
in a low-risk population. The investigators expect more profound changes in methylation state
of the NR3C1 and other promotor regions in their cohort of mothers exposed to important
prenatal stress. Secondly, the methylation of oxytocin receptor regions will be studied in
relation to attachment and bonding.
An important overall goal of the project is to develop a Perinatal Stress Calculator that
studies the value of the different neonatal, endocrinological, psychological and
physiological stress-related parameters to predict differences in psychomotor, cognitive,
behavioral, and emotional development. This longitudinal study design will enable the
investigators to use the perinatal stress calculator to study the relation between the
perinatal stress parameters and later developmental disabilities such as motor impairment,
cognitive deficits, language delay but also social and behavioral problems such as
attentional deficits and emotional self-regulation dysfunction.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | October 2022 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 34 Weeks |
Eligibility |
Inclusion Criteria: - Preterm infants born before 34 weeks gestational age and/or with a birth weight lower than 1500g and their parents Exclusion Criteria: - Age < 18yr. - Unable to speak and understand Dutch, French or English - Unstable medical (somatic and/or psychiatric) disease in the parent(s) - The presence of a major congenital malformation in the preterm infant |
Country | Name | City | State |
---|---|---|---|
Belgium | UZLEUVEN | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven | KU Leuven |
Belgium,
Aarnoudse-Moens CS, Weisglas-Kuperus N, van Goudoever JB, Oosterlaan J. Meta-analysis of neurobehavioral outcomes in very preterm and/or very low birth weight children. Pediatrics. 2009 Aug;124(2):717-28. doi: 10.1542/peds.2008-2816. Epub 2009 Jul 27. — View Citation
André M, Lamblin MD, d'Allest AM, Curzi-Dascalova L, Moussalli-Salefranque F, S Nguyen The T, Vecchierini-Blineau MF, Wallois F, Walls-Esquivel E, Plouin P. Electroencephalography in premature and full-term infants. Developmental features and glossary. Neurophysiol Clin. 2010 May;40(2):59-124. doi: 10.1016/j.neucli.2010.02.002. Epub 2010 Mar 16. Review. — View Citation
Bosmans G, Braet C, Koster E, De Raedt R. Attachment security and attentional breadth toward the attachment figure in middle childhood. J Clin Child Adolesc Psychol. 2009 Nov;38(6):872-82. doi: 10.1080/15374410903258926. — View Citation
Bosmans G, De Raedt R, Braet C. The invisible bonds: does the secure base script of attachment influence children's attention toward their mother? J Clin Child Adolesc Psychol. 2007 Oct-Dec;36(4):557-67. — View Citation
Bottomley C, Van Belle V, Mukri F, Kirk E, Van Huffel S, Timmerman D, Bourne T. The optimal timing of an ultrasound scan to assess the location and viability of an early pregnancy. Hum Reprod. 2009 Aug;24(8):1811-7. doi: 10.1093/humrep/dep084. Epub 2009 Apr 10. — View Citation
Bowlby J, Attachment and Loss: Attachment V, Basic Books, 1969.
Braeken MA, Kemp AH, Outhred T, Otte RA, Monsieur GJ, Jones A, Van den Bergh BR. Pregnant mothers with resolved anxiety disorders and their offspring have reduced heart rate variability: implications for the health of children. PLoS One. 2013 Dec 10;8(12):e83186. doi: 10.1371/journal.pone.0083186. eCollection 2013. — View Citation
Carpenter LL, Carvalho JP, Tyrka AR, Wier LM, Mello AF, Mello MF, Anderson GM, Wilkinson CW, Price LH. Decreased adrenocorticotropic hormone and cortisol responses to stress in healthy adults reporting significant childhood maltreatment. Biol Psychiatry. 2007 Nov 15;62(10):1080-7. Epub 2007 Jul 27. — View Citation
Cassidy J. The nature of the child's ties. Handbook of attachment: Theory, research, and clinical implications 2:3-22, 1999.
Cecchini M, Baroni E, Di Vito C, Piccolo F, Lai C. Newborn preference for a new face vs. a previously seen communicative or motionless face. Infant Behav Dev. 2011 Jun;34(3):424-33. doi: 10.1016/j.infbeh.2011.04.002. Epub 2011 May 8. — View Citation
Chrousos GP. Stress and disorders of the stress system. Nat Rev Endocrinol. 2009 Jul;5(7):374-81. doi: 10.1038/nrendo.2009.106. Epub 2009 Jun 2. Review. — View Citation
Coolen MW, Statham AL, Gardiner-Garden M, Clark SJ. Genomic profiling of CpG methylation and allelic specificity using quantitative high-throughput mass spectrometry: critical evaluation and improvements. Nucleic Acids Res. 2007;35(18):e119. Epub 2007 Sep 13. — View Citation
Dykas MJ, Ehrlich KB, Cassidy J. Links between attachment and social information processing: examination of intergenerational processes. Adv Child Dev Behav. 2011;40:51-94. Review. — View Citation
Feldman R, Gordon I, Schneiderman I, Weisman O, Zagoory-Sharon O. Natural variations in maternal and paternal care are associated with systematic changes in oxytocin following parent-infant contact. Psychoneuroendocrinology. 2010 Sep;35(8):1133-41. doi: 10.1016/j.psyneuen.2010.01.013. Epub 2010 Feb 12. — View Citation
Feldman R, Gordon I, Zagoory-Sharon O. Maternal and paternal plasma, salivary, and urinary oxytocin and parent-infant synchrony: considering stress and affiliation components of human bonding. Dev Sci. 2011 Jul;14(4):752-61. doi: 10.1111/j.1467-7687.2010.01021.x. Epub 2010 Dec 16. — View Citation
Feldman R, Gordon I, Zagoory-Sharon O. The cross-generation transmission of oxytocin in humans. Horm Behav. 2010 Sep;58(4):669-76. doi: 10.1016/j.yhbeh.2010.06.005. Epub 2010 Jun 15. — View Citation
Feldman R, Weller A, Zagoory-Sharon O, Levine A. Evidence for a neuroendocrinological foundation of human affiliation: plasma oxytocin levels across pregnancy and the postpartum period predict mother-infant bonding. Psychol Sci. 2007 Nov;18(11):965-70. — View Citation
Fisher DA. Thyroid system immaturities in very low birth weight premature infants. Semin Perinatol. 2008 Dec;32(6):387-97. doi: 10.1053/j.semperi.2008.09.003. Review. — View Citation
Gitau R, Fisk NM, Teixeira JM, Cameron A, Glover V. Fetal hypothalamic-pituitary-adrenal stress responses to invasive procedures are independent of maternal responses. J Clin Endocrinol Metab. 2001 Jan;86(1):104-9. — View Citation
Glover V, O'Connor TG, O'Donnell K. Prenatal stress and the programming of the HPA axis. Neurosci Biobehav Rev. 2010 Sep;35(1):17-22. doi: 10.1016/j.neubiorev.2009.11.008. Epub 2009 Nov 13. Review. — View Citation
Glover V. Annual Research Review: Prenatal stress and the origins of psychopathology: an evolutionary perspective. J Child Psychol Psychiatry. 2011 Apr;52(4):356-67. doi: 10.1111/j.1469-7610.2011.02371.x. Epub 2011 Jan 19. Review. — View Citation
Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. — View Citation
Heim C, Newport DJ, Bonsall R, Miller AH, Nemeroff CB. Altered pituitary-adrenal axis responses to provocative challenge tests in adult survivors of childhood abuse. Am J Psychiatry. 2001 Apr;158(4):575-81. — View Citation
Heim C, Shugart M, Craighead WE, Nemeroff CB. Neurobiological and psychiatric consequences of child abuse and neglect. Dev Psychobiol. 2010 Nov;52(7):671-90. doi: 10.1002/dev.20494. Review. — View Citation
Hompes T, Izzi B, Gellens E, Morreels M, Fieuws S, Pexsters A, Schops G, Dom M, Van Bree R, Freson K, Verhaeghe J, Spitz B, Demyttenaere K, Glover V, Van den Bergh B, Allegaert K, Claes S. Investigating the influence of maternal cortisol and emotional state during pregnancy on the DNA methylation status of the glucocorticoid receptor gene (NR3C1) promoter region in cord blood. J Psychiatr Res. 2013 Jul;47(7):880-91. doi: 10.1016/j.jpsychires.2013.03.009. Epub 2013 Apr 6. — View Citation
Izzi B, Decallonne B, Devriendt K, Bouillon R, Vanderschueren D, Levtchenko E, de Zegher F, Van den Bruel A, Lambrechts D, Van Geet C, Freson K. A new approach to imprinting mutation detection in GNAS by Sequenom EpiTYPER system. Clin Chim Acta. 2010 Dec 14;411(23-24):2033-9. doi: 10.1016/j.cca.2010.08.034. Epub 2010 Aug 31. — View Citation
Kochanska G, Murray KT, Harlan ET. Effortful control in early childhood: continuity and change, antecedents, and implications for social development. Dev Psychol. 2000 Mar;36(2):220-32. — View Citation
Lockwood CJ, Radunovic N, Nastic D, Petkovic S, Aigner S, Berkowitz GS. Corticotropin-releasing hormone and related pituitary-adrenal axis hormones in fetal and maternal blood during the second half of pregnancy. J Perinat Med. 1996;24(3):243-51. — View Citation
Luts J., Molenberghs G., Verbeke G., Van Huffel S., Suykens J.A.K. A mixed effects least squares support vector machine model for classification of longitudinal data. Statistics & Data Analysis 56(3): 611-628, 2012.
McGowan PO, Sasaki A, D'Alessio AC, Dymov S, Labonté B, Szyf M, Turecki G, Meaney MJ. Epigenetic regulation of the glucocorticoid receptor in human brain associates with childhood abuse. Nat Neurosci. 2009 Mar;12(3):342-8. doi: 10.1038/nn.2270. — View Citation
Meaney MJ, Szyf M, Seckl JR. Epigenetic mechanisms of perinatal programming of hypothalamic-pituitary-adrenal function and health. Trends Mol Med. 2007 Jul;13(7):269-77. Epub 2007 Jun 4. — View Citation
Meyer-Lindenberg A, Tost H. Neural mechanisms of social risk for psychiatric disorders. Nat Neurosci. 2012 Apr 15;15(5):663-8. doi: 10.1038/nn.3083. Review. — View Citation
Mirescu C, Peters JD, Gould E. Early life experience alters response of adult neurogenesis to stress. Nat Neurosci. 2004 Aug;7(8):841-6. Epub 2004 Jul 25. — View Citation
Mrdalj J, Pallesen S, Milde AM, Jellestad FK, Murison R, Ursin R, Bjorvatn B, Grønli J. Early and later life stress alter brain activity and sleep in rats. PLoS One. 2013 Jul 26;8(7):e69923. doi: 10.1371/journal.pone.0069923. Print 2013. — View Citation
Murray CJ, Vos T, Lozano R, Naghavi M, Flaxman AD, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, Abraham J, Ackerman I, Aggarwal R, Ahn SY, Ali MK, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Bahalim AN, Barker-Collo S, Barrero LH, Bartels DH, Basáñez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, Bernabé E, Bhalla K, Bhandari B, Bikbov B, Bin Abdulhak A, Birbeck G, Black JA, Blencowe H, Blore JD, Blyth F, Bolliger I, Bonaventure A, Boufous S, Bourne R, Boussinesq M, Braithwaite T, Brayne C, Bridgett L, Brooker S, Brooks P, Brugha TS, Bryan-Hancock C, Bucello C, Buchbinder R, Buckle G, Budke CM, Burch M, Burney P, Burstein R, Calabria B, Campbell B, Canter CE, Carabin H, Carapetis J, Carmona L, Cella C, Charlson F, Chen H, Cheng AT, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahiya M, Dahodwala N, Damsere-Derry J, Danaei G, Davis A, De Leo D, Degenhardt L, Dellavalle R, Delossantos A, Denenberg J, Derrett S, Des Jarlais DC, Dharmaratne SD, Dherani M, Diaz-Torne C, Dolk H, Dorsey ER, Driscoll T, Duber H, Ebel B, Edmond K, Elbaz A, Ali SE, Erskine H, Erwin PJ, Espindola P, Ewoigbokhan SE, Farzadfar F, Feigin V, Felson DT, Ferrari A, Ferri CP, Fèvre EM, Finucane MM, Flaxman S, Flood L, Foreman K, Forouzanfar MH, Fowkes FG, Fransen M, Freeman MK, Gabbe BJ, Gabriel SE, Gakidou E, Ganatra HA, Garcia B, Gaspari F, Gillum RF, Gmel G, Gonzalez-Medina D, Gosselin R, Grainger R, Grant B, Groeger J, Guillemin F, Gunnell D, Gupta R, Haagsma J, Hagan H, Halasa YA, Hall W, Haring D, Haro JM, Harrison JE, Havmoeller R, Hay RJ, Higashi H, Hill C, Hoen B, Hoffman H, Hotez PJ, Hoy D, Huang JJ, Ibeanusi SE, Jacobsen KH, James SL, Jarvis D, Jasrasaria R, Jayaraman S, Johns N, Jonas JB, Karthikeyan G, Kassebaum N, Kawakami N, Keren A, Khoo JP, King CH, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Laden F, Lalloo R, Laslett LL, Lathlean T, Leasher JL, Lee YY, Leigh J, Levinson D, Lim SS, Limb E, Lin JK, Lipnick M, Lipshultz SE, Liu W, Loane M, Ohno SL, Lyons R, Mabweijano J, MacIntyre MF, Malekzadeh R, Mallinger L, Manivannan S, Marcenes W, March L, Margolis DJ, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGill N, McGrath J, Medina-Mora ME, Meltzer M, Mensah GA, Merriman TR, Meyer AC, Miglioli V, Miller M, Miller TR, Mitchell PB, Mock C, Mocumbi AO, Moffitt TE, Mokdad AA, Monasta L, Montico M, Moradi-Lakeh M, Moran A, Morawska L, Mori R, Murdoch ME, Mwaniki MK, Naidoo K, Nair MN, Naldi L, Narayan KM, Nelson PK, Nelson RG, Nevitt MC, Newton CR, Nolte S, Norman P, Norman R, O'Donnell M, O'Hanlon S, Olives C, Omer SB, Ortblad K, Osborne R, Ozgediz D, Page A, Pahari B, Pandian JD, Rivero AP, Patten SB, Pearce N, Padilla RP, Perez-Ruiz F, Perico N, Pesudovs K, Phillips D, Phillips MR, Pierce K, Pion S, Polanczyk GV, Polinder S, Pope CA 3rd, Popova S, Porrini E, Pourmalek F, Prince M, Pullan RL, Ramaiah KD, Ranganathan D, Razavi H, Regan M, Rehm JT, Rein DB, Remuzzi G, Richardson K, Rivara FP, Roberts T, Robinson C, De Leòn FR, Ronfani L, Room R, Rosenfeld LC, Rushton L, Sacco RL, Saha S, Sampson U, Sanchez-Riera L, Sanman E, Schwebel DC, Scott JG, Segui-Gomez M, Shahraz S, Shepard DS, Shin H, Shivakoti R, Singh D, Singh GM, Singh JA, Singleton J, Sleet DA, Sliwa K, Smith E, Smith JL, Stapelberg NJ, Steer A, Steiner T, Stolk WA, Stovner LJ, Sudfeld C, Syed S, Tamburlini G, Tavakkoli M, Taylor HR, Taylor JA, Taylor WJ, Thomas B, Thomson WM, Thurston GD, Tleyjeh IM, Tonelli M, Towbin JA, Truelsen T, Tsilimbaris MK, Ubeda C, Undurraga EA, van der Werf MJ, van Os J, Vavilala MS, Venketasubramanian N, Wang M, Wang W, Watt K, Weatherall DJ, Weinstock MA, Weintraub R, Weisskopf MG, Weissman MM, White RA, Whiteford H, Wiebe N, Wiersma ST, Wilkinson JD, Williams HC, Williams SR, Witt E, Wolfe F, Woolf AD, Wulf S, Yeh PH, Zaidi AK, Zheng ZJ, Zonies D, Lopez AD, AlMazroa MA, Memish ZA. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2197-223. doi: 10.1016/S0140-6736(12)61689-4. Erratum in: Lancet. 2013 Feb 23;381(9867):628. AlMazroa, Mohammad A [added]; Memish, Ziad A [added]. — View Citation
Oberlander TF, Weinberg J, Papsdorf M, Grunau R, Misri S, Devlin AM. Prenatal exposure to maternal depression, neonatal methylation of human glucocorticoid receptor gene (NR3C1) and infant cortisol stress responses. Epigenetics. 2008 Mar-Apr;3(2):97-106. — View Citation
Palmu K, Kirjavainen T, Stjerna S, Salokivi T, Vanhatalo S. Sleep wake cycling in early preterm infants: comparison of polysomnographic recordings with a novel EEG-based index. Clin Neurophysiol. 2013 Sep;124(9):1807-14. doi: 10.1016/j.clinph.2013.03.010. Epub 2013 Apr 30. — View Citation
Patel J, Landers K, Li H, Mortimer RH, Richard K. Thyroid hormones and fetal neurological development. J Endocrinol. 2011 Apr;209(1):1-8. doi: 10.1530/JOE-10-0444. Epub 2011 Jan 6. Review. — View Citation
Pechtel P, Pizzagalli DA. Effects of early life stress on cognitive and affective function: an integrated review of human literature. Psychopharmacology (Berl). 2011 Mar;214(1):55-70. doi: 10.1007/s00213-010-2009-2. Epub 2010 Sep 24. Review. — View Citation
Reijneveld SA, de Kleine MJ, van Baar AL, Kollée LA, Verhaak CM, Verhulst FC, Verloove-Vanhorick SP. Behavioural and emotional problems in very preterm and very low birthweight infants at age 5 years. Arch Dis Child Fetal Neonatal Ed. 2006 Nov;91(6):F423-8. Epub 2006 Jul 28. — View Citation
Reuss ML, Paneth N, Pinto-Martin JA, Lorenz JM, Susser M. The relation of transient hypothyroxinemia in preterm infants to neurologic development at two years of age. N Engl J Med. 1996 Mar 28;334(13):821-7. — View Citation
Sai FZ. The role of the mother's voice in developing mother's face preference: Evidence for intermodal perception at birth.
Singer LT, Fulton S, Davillier M, Koshy D, Salvator A, Baley JE. Effects of infant risk status and maternal psychological distress on maternal-infant interactions during the first year of life. J Dev Behav Pediatr. 2003 Aug;24(4):233-41. — View Citation
Smith SL, Haley S, Slater H, Moyer-Mileur LJ. Heart rate variability during caregiving and sleep after massage therapy in preterm infants. Early Hum Dev. 2013 Aug;89(8):525-9. doi: 10.1016/j.earlhumdev.2013.01.004. Epub 2013 Jan 27. — View Citation
Spruyt A, Clarysse J, Vansteenwegen D, Baeyens F, Hermans D. Affect 4.0: a free software package for implementing psychological and psychophysiological experiments. Exp Psychol. 2010;57(1):36-45. doi: 10.1027/1618-3169/a000005. — View Citation
Unternaehrer E, Luers P, Mill J, Dempster E, Meyer AH, Staehli S, Lieb R, Hellhammer DH, Meinlschmidt G. Dynamic changes in DNA methylation of stress-associated genes (OXTR, BDNF ) after acute psychosocial stress. Transl Psychiatry. 2012 Aug 14;2:e150. doi: 10.1038/tp.2012.77. — View Citation
Van Beek Y, Hopkins B, Hoeksma JB. Development of communicative behaviors in preterm infants: The effects of birthweight status and gestational age. Infant Behavior and Development 17(2):107-117, 1994.
Van Belle V, Neven P, Harvey V, Van Huffel S, Suykens JA, Boyd S. Risk group detection and survival function estimation for interval coded survival methods. Neurocomputing 112:200-210, 2013.
Van Belle VM, Van Calster B, Timmerman D, Bourne T, Bottomley C, Valentin L, Neven P, Van Huffel S, Suykens JA, Boyd S. A mathematical model for interpretable clinical decision support with applications in gynecology. PLoS One. 2012;7(3):e34312. doi: 10.1371/journal.pone.0034312. Epub 2012 Mar 29. — View Citation
Van den Bergh BR, Mennes M, Oosterlaan J, Stevens V, Stiers P, Marcoen A, Lagae L. High antenatal maternal anxiety is related to impulsivity during performance on cognitive tasks in 14- and 15-year-olds. Neurosci Biobehav Rev. 2005 Apr;29(2):259-69. Epub 2004 Dec 15. — View Citation
Van den Bergh BR, Mulder EJ, Mennes M, Glover V. Antenatal maternal anxiety and stress and the neurobehavioural development of the fetus and child: links and possible mechanisms. A review. Neurosci Biobehav Rev. 2005 Apr;29(2):237-58. Review. — View Citation
van Londen WM, Juffer F, van Ijzendoorn MH. Attachment, cognitive, and motor development in adopted children: short-term outcomes after international adoption. J Pediatr Psychol. 2007 Nov-Dec;32(10):1249-58. Epub 2007 Aug 19. — View Citation
van Putten MJ, Tavy DL. Continuous quantitative EEG monitoring in hemispheric stroke patients using the brain symmetry index. Stroke. 2004 Nov;35(11):2489-92. Epub 2004 Oct 7. — View Citation
Vangeel EB, Izzi B, Hompes T, Vansteelandt K, Lambrechts D, Freson K, Claes S. DNA methylation in imprinted genes IGF2 and GNASXL is associated with prenatal maternal stress. Genes Brain Behav. 2015 Nov;14(8):573-82. doi: 10.1111/gbb.12249. Epub 2015 Sep 23. — View Citation
Varrault A, Gueydan C, Delalbre A, Bellmann A, Houssami S, Aknin C, Severac D, Chotard L, Kahli M, Le Digarcher A, Pavlidis P, Journot L. Zac1 regulates an imprinted gene network critically involved in the control of embryonic growth. Dev Cell. 2006 Nov;11(5):711-22. — View Citation
Walton GE, Bower NJA, Bower TGR. Recognition of familiar faces by newborns. Infant Behavior and Development 15(2):265-269, 1992.
World Health Organization (2002). Iron and folate supplementation. Integrated management of pregnancy and childbirth (IMPAC). Standards for Maternal and Neonatal Care. http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/iron_folate_supplementation.pdf The Department of Making Pregnancy Safer, World Health Organization.
* Note: There are 57 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Attachment behavior (will be assessed using questionnaires and both free and structured observations of the child-parent interaction) | 24 months | ||
Secondary | Psychomotor development (will be assessed using Infant Scales of Development) | 24 months | ||
Secondary | Cognitive development (will be assessed using Infant Scales of Development) | 24 months | ||
Secondary | Cognitive development (executive functioning will be assessed by the Snack Delay Task) | 24 months | ||
Secondary | Language development (will be assessed using Infant Scales of Development) | 24 months | ||
Secondary | Language development (will be assessed using the NCDI-2A) | 24 months | ||
Secondary | Behavioral development (will be assessed using Infant Scales of Development ) | 24 months | ||
Secondary | Behavioral development (will be assessed by questioning both parents and external caregivers) | 24 months | ||
Secondary | Physical development (will be assessed by measuring children's height) | 24 months | ||
Secondary | Physical development (will be assessed by measuring children's weight) | 24 months | ||
Secondary | Physical development (will be assessed by measuring children's head circumference) | 24 months | ||
Secondary | Emotional development (will be assessed using the Bayley Scales of Infant Development III) | 24 months | ||
Secondary | Emotional development (will be assessed by questioning both parents and external caregivers) | 24 months |
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