NIDCAP: Testing the Effectiveness of a Relationship-Based Comprehensive Intervention

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NIDCAP: Testing the Effectiveness of a

Relationship-Based Comprehensive Intervention

Research success means discovery of an orderly pattern that had not been recognized previously. The ﬁrst Newborn Individualized Develop-mental Care and Assessment Program (NIDCAP) investigation in 1986, a small phase-lag trial, was dismissed because of design shortcomings.1

Nevertheless, it inspired some investigators. More rigorous trials soon followed and bore out the initial study’s results.2–12

A recent randomized, controlled trial (RCT) with the largest sample to date (⬃160 infants) from Leiden, Netherlands,13_{did not show the beneﬁts of}

this program as previously reported in multiple publications. What might account for this surprising failure to reject the null hypothesis?

Several points are worthy of consideration:⬃15 infants total were newly enrolled every month in this study (ie, ⬃2 new intervention group infants per week), which is an extraordinary number of infants in a small unit in which NIDCAP is not standard of care and represents a Herculean task. Weekly observations and report formulations consti-tute only a small part of NIDCAP. The relationship with each family and staff is the most important aspect of NIDCAP. Relationships take time. Moreover, the heterogeneity of the sample was large: 2 hospitals were involved, both with small 1-room NICUs, 2 intensive care beds, and 14 beds total in 1 of the hospitals and 8 intensive care and 21 beds total in the other. Approximately 40% of the study infants were transported to the study NICUs, which suggests that they were at higher risk than inborn infants. Parental consent in⬍48 hours for a transported infant seems near impossible and likely led to variable NIDCAP starting times. A number of infants received as little as a single NIDCAP observation before transfer to an outlying hospital, which added to the lack of consistency and ﬁdelity in the intervention.

The remarkably good Bayley results observed in both groups point to likely comparability of NICU care received. Somewhat puzzling is the unusually high incidence of sepsis of almost 50% in both groups and the large number of children with signiﬁcant later disabilities (12%– 20%). That the Leiden study failed to reject the null hypothesis of sta-tistical group mean differences for its sample implies that the groups were not different at outcome. It does not imply, however, that the NIDCAP was not effective. A failure to reject the null hypothesis is quite different from accepting it.14_{There are always multiple potential}

inter-vening factors to account for such failure, some of which were pointed out above.

Of interest also is the publication, in this issue ofPediatrics, of the results of a Canadian (Edmonton) RCT15_{with a sample of}⬎_{100 infants,}

which statistically reject the null hypothesis of outcome comparability after NIDCAP. What accounts for the opposing results? In both trials the intervention ended with infant transfers to a community hospital. How-ever, the Edmonton group’s NIDCAP care was strikingly different from that

AUTHOR:Heidelise Als, PhD

Neurobehavioral Infant and Child Studies, Children’s Hospital Boston, Boston, Massachusetts

ABBREVIATIONS

NIDCAP—Newborn Individualized Developmental Care and Assessment Program

RCT—randomized, controlled trial

Opinions expressed in this commentary are those of the author and not necessarily those of the American Academy of Pediatrics or its Committees.

www.pediatrics.org/cgi/doi/10.1542/peds.2009-1646

doi:10.1542/peds.2009-1646

Accepted for publication Jul 20, 2009

Address correspondence to Heidelise Als, PhD, Children’s Hospital Boston, Neurobehavioral Infant and Child Studies, Enders Pediatric Research Building, En107, 320 Longwood Ave, Boston, MA 02115. E-mail: [email protected] or [email protected]

PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).

FINANCIAL DISCLOSURE:The author has indicated she has no ﬁnancial relationships relevant to this article to disclose.

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of the Leiden group. Experimental infants in the Edmonton study were largely cared for by NIDCAP-certified nurses who did not care for the control infants, thus increasing intervention fidelity. An-other difference was the much-longer Edmonton intake phase, which presum-ably allowed for more in-depth interven-tion guidance and follow-through. In ad-dition, the involvement of only 1 hospital allowed for (1) much greater homogene-ity of the sample, with⬎90% of the Edm-onton infants inborn, (2) the lower ges-tational ages at birth (ie, infants at higher risk with more need and room for intervention), and (3) the large size of the NICU, with 55 beds, which reduces trans-fers elsewhere. Given the improved chances to make a difference and the higher fidelity of NIDCAP implementation, the Edmonton group showed signifi-cantly reduced lengths of hospital stays

and signiﬁcantly fewer Bayley II scores of⬍70 for the Experimental group.

What may one conclude from these trials? The NIDCAP approach is indeed a complex, comprehensive, staff-intensive, relationship-based interven-tion. It requires the building of connec-tions and trust with study families and professional caregivers. NIDCAP is not an intervention of quantity of report writing but of quality of interaction and guidance. These relationships re-quire time to develop and blossom. The measurement of fidelity of NIDCAP implementation is of great impor-tance. Medication trials insist on the purity and accuracy of dose delivered, and so must the NIDCAP intervention, although such an intervention is more difficult to quantify. NIDCAP training in-cludes a measurement tool of opera-tionally defined rating scales for the

physical and caregiving proﬁle ob-served.16_{Serially conducted}

measure-ments by blinded observers should be used if one wants to demonstrate a re-liable measure of care implementation ﬁdelity. The quality of care in a nursery should also be measured before-hand to estimate the feasibility of a NIDCAP RCT. The NIDCAP Federation In-ternational (NFI) developed a nursery-certiﬁcation instrument that consists of a larger number of such scales that permit gauging of quality of an entire nursery system’s developmental care implementation.17 _{Scores that range}

consistently above a certain level indi-cate that a NIDCAP study may no longer be indicated; such scores suggest that the NIDCAP philosophy and quality of care have become standard in such nurseries, which is the ultimate goal of NIDCAP work.

REFERENCES

1. Als H, Lawhon G, Brown E, et al. Individualized behavioral and environmental care for the very low birth weight preterm infant at high risk for bronchopulmonary dysplasia: neonatal intensive care unit and developmental outcome.Pediatrics.1986;78(6):1123–1132

2. Als H, Lawhon G, Duffy FH, McAnulty GB, Gibes-Grossman R, Blickman JG. Individualized develop-mental care for the very low-birth-weight preterm infant: medical and neurofunctional effects.

JAMA.1994;272(11):853– 858

3. Fleisher BF, VandenBerg KA, Constantinou J, et al. Individualized developmental care for very-low-birth-weight premature infants [published correction appears inClin Pediatr (Phila). 1996;35(3): 172].Clin Pediatr (Phila).1995;34(10):523–529

4. Buehler DM, Als H, Duffy FH, McAnulty GB, Liederman J. Effectiveness of individualized develop-mental care for low-risk preterm infants: behavioral and electrophysiological evidence. Pediat-rics.1995;96(5 pt 1):923–932

5. Stevens B, Petryshen P, Hawkins J, Smith B, Taylor P. Developmental versus conventional care: a comparison of clinical outcomes for very low birth weight infants.Can J Nurs Res.1996;28(4): 97–113

6. Petryshen P, Stevens B, Hawkins J, Stewart M. Comparing nursing costs for preterm infants receiving conventional vs. developmental care.Nurs Econ.1997;15(3):138 –150

7. Westrup B, Kleberg A, von Eichwald K, Stjernqvist K, Lagercrantz H. A randomized controlled trial to evaluate the effects of the Newborn Individualized Developmental Care and Assessment Pro-gram in a Swedish setting.Pediatrics.2000;105(1 pt 1):66 –72

8. Als H, Gilkerson L, Duffy FH, et al. A three-center randomized controlled trial of individualized developmental care for very low birth weight preterm infants: medical, neurodevelopmental, parenting and caregiving effects.J Dev Behav Pediatr.2003;24(6):399 – 408

9. Kleberg A, Westrup B, Stjernqvist K, Lagercrantz H. Indications of improved cognitive development at one year of age among infants born very prematurely who received care based on the Newborn Individualized Developmental Care and Assessment Program (NIDCAP).Early Hum Dev.2002;68(2): 83–91

10. Westrup B, Bo¨hm B, Lagercrantz H, Stjernqvist K. Preschool outcome in children born very pre-maturely and cared for according to the Newborn Individualized Developmental Care and Assess-ment Program (NIDCAP).Acta Paediatr.2004;93(4):498 –507

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11. Als H, Duffy F, McAnulty GB, et al. Early experience alters brain function and structure.Pediatrics.

2004;113(4):846 – 857

12. McAnulty G, Duffy F, Butler S, Bernstein J, Zurakowski D, Als H. Effects of the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) at age 8 years: preliminary data.Clin Pediatr (Phila).2009; In press

13. 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;123(4):1081–1087

14. Fisher R.The Designs of Experiments. 8th ed. Edinburgh, Scotland: Hafner; 1966

15. Peters K, Rosychuk R, Hendon L, Cote´ J, McPherson C, Tyebkhan J. Improvement of short- and long-term outcomes for very low birth weight infants: the Edmonton NIDCAP trial.Pediatrics.

2009;124(4):1009 –1020

16. Als H, Buehler D, Gilkerson L, Smith K.Proﬁle of the Nursery Environment and of Care Components. Template Manual: Part I—Revised. Boston, MA: NIDCAP Federation International; 1990, revised 2008

17. Smith K, Buehler D, Als H.NIDCAP Nursery Certiﬁcation Criterion Scales. Boston, MA: NIDCAP Federation International; 2009

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DOI: 10.1542/peds.2009-1646 originally published online September 28, 2009;

2009;124;1208

Pediatrics

Heidelise Als

Intervention

NIDCAP: Testing the Effectiveness of a Relationship-Based Comprehensive

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DOI: 10.1542/peds.2009-1646 originally published online September 28, 2009;

2009;124;1208

Pediatrics

Heidelise Als

Intervention

NIDCAP: Testing the Effectiveness of a Relationship-Based Comprehensive

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