A randomized controlled trial of clinic-based and home-based interventions in comparison with usual care for preterm infants: Effects and mediators
Introduction
Preterm births with very-low-birth-weight (VLBW; birth weight < 1500 g) exert unfavorable effects on not only maternal psychological wellness (Saigal & Doyle, 2008) and mother–infant interaction (Bozzette, 2007) but also child developmental outcomes (Aarnoudse-Moens et al., 2009, Saigal and Doyle, 2008). In Western countries, various interventions have been developed for preterm infants that yielded small motor benefits in early infancy and moderate cognitive benefits from infancy to preschool age (Orton et al., 2009, Spittle et al., 2012, Vanderveen et al., 2009), but inconclusive effects on behavioral outcome (Blair, 2002, Brooks-Gunn et al., 1993, Kaaresen et al., 2008, Kleberg et al., 2000, Koldewijn et al., 2010, Koldewijn et al., 2005, Koldewijn et al., 2009, Nordhov et al., 2012, Spencer-Smith et al., 2012, Spittle et al., 2010, Westrup et al., 2004). The investigation in Eastern societies has been limited to only one study in China, which showed cognitive benefits (Bao, Sun, Wei, & Coo, 1999). Given substantial variations in health care systems and family structures among societies, the effect of intervention programs needs to be investigated in relevant cultural contexts.
Despite documented effectiveness, the social and developmental pathways underlying the interventions remain unclear. Behavioral interchanges between an infant and his/her caregiver have been proposed as a vehicle for the development of cognitive, language, psychomotor, and socio-emotional functions (Browne, 2003, Dunn et al., 2006, Geva and Feldman, 2008, Ramey et al., 1984). Early responsive parenting and focused infant attention during dyadic interaction have been found to predict later favorable cognitive, language, and behavioral outcomes in both term and preterm infants (Forcada-Guex et al., 2006, Lawson and Ruff, 2004, Schmidt and Lawson, 2002, Smith et al., 2006). One study of preterm infants reported that improvement in maternal responsiveness at 30 months of age mediated an intervention's effect on cognitive outcomes at 36 months of age (Mahoney, Boyce, Fewell, Spiker, & Wheeden, 1998). In addition, emotional regulation has been proposed as the antecedent variable of behavioral outcomes (Geva and Feldman, 2008, Mahoney et al., 1998). Inadequate stress regulatory behavior in the first year of life was found to predict behavioral problems at 5 years of age in preterm infants (Feldman, 2009). Partnership with a parent and advanced attention control for emotional regulation, which form the foundation of subsequent development (Carpenter et al., 1998, Lowe et al., 2010) and behavior (Bell and Deater-Deckard, 2007, Calkins and Fox, 2002), are developed in infants at 12 months of age. This time period therefore provides a critical window to investigate the social and developmental pathways underlying effective interventions.
Early intervention for preterm infants in Taiwan has been limited to in-hospital developmental care at certain medical centers. To replicate the benefits of home visits from Western experiences (Brooks-Gunn et al., 1993, Koldewijn et al., 2010, Newnham et al., 2009) and to adapt intervention programs to the high accessibility of clinic visits for after-discharge services in Taiwan, we developed a clinic-based intervention program (CBIP) and a home-based intervention program (HBIP) for VLBW preterm infants in Taiwan from hospitalization until 12 months of age (corrected for prematurity) (Chen et al., 2013). The CBIP and HBIP contained similar child-, parent- and dyad-focused services and the interventions after discharge were respectively delivered at clinic and at home. Compared with the usual care program (UCP), these programs significantly reduced the incidence of retinopathy and feeding desaturation, and enhanced weight gain in the neonatal period (Chen et al., 2013).
This study therefore extended our research to examine the long-term effectiveness of the CBIP and HBIP in comparison with UCP on VLBW preterm infants’ developmental and behavioral outcomes at 24 months of age. Additionally, this study investigated whether mother–infant interaction and infant emotional regulation at 12 months mediated the interventions’ effects on subsequent developmental and behavioral outcomes for the infants. We expected that the CBIP and HBIP would enhance infants’ developmental and behavioral performance at 24 months of age through better mother–infant interaction and infant emotional regulation at 12 months of age.
Section snippets
Participants
This randomized controlled trial (RCT) enrolled VLBW preterm infants from three hospitals in northern Taiwan from 2006 to 2008 (Chen et al., 2013). The inclusion criteria were birth weight <1500 g, gestational age <37 weeks, admission to the study hospital within 7 days of birth, singleton birth or the first child of twins or multiples (equal contribution from each family to the data), and an absence of congenital anomalies or severe neonatal diseases (seizure, hydrocephalus,
Results
Of the 211 VLBW preterm infants enrolled in the RCT, 29 were early dropouts, and 178 remained in the study (Fig. 1). The birth and demographic characteristics of the preterm infants who ever returned for follow-up (n = 161) were similar to those of the infants who did not return (n = 17). Of those infants who returned, no characteristics differed among the three groups of preterm infants (Table 2).
Discussion
The two intervention programs appeared to yield differential effects on dyadic interaction and infant emotional regulation in VLBW preterm infants at 12 months of age. The CBIP had marginal effects for mother–infant interaction and emotional regulation, enhancing maternal and dyadic interactive behaviors and decreasing the duration of escape; whereas the HBIP was effective only for emotional regulation, decreasing the duration of orientation to a toy and increasing the duration of orientation
Limitations
The RCT design is the strength of the study. However, the homogeneity of the participants, who resided in a city with adequate medical and social resources, may limit the generalizability of our results. Additionally, the laboratory setting of the toy-behind-barrier and free-play procedures may not reflect a natural situation in daily life, although this setting allows observation of infant and maternal behaviors in a standardized way. Finally, estimation of our sample size was based on the
Conclusions
The results of this study demonstrated the effectiveness of the interventions in improving the cognitive, motor, and behavioral outcomes of Taiwanese VLBW preterm infants by 24 months of age. Furthermore, early-improved mother–infant interaction and infant emotional regulation appeared to respectively mediate the interventions’ effects on the infants’ cognitive and behavioral outcomes. Our findings provide important insights into the design of intervention programs and intriguing clues
Funding source
All phases of this study were supported by two grants from the National Health Research Institute (NHRI-EX98-9519PI, NHRI-EX102-10106PI) and a grant from the National Science Council (NSC98-2314-B-002-010-MY3) in Taiwan.
Financial disclosure
None
Conflict of interest
None
Clinical trial registration
This randomized controlled trial has been registered at www.clinicaltrials.gov (registry title: Early intervention for preterm infants; number: NCT00173108).
Acknowledgements
This study received grant support from the National Health Research Institute (NHRI-EX98-9519PI and NHRI-EX102-10106PI) and the National Science Council (NSC98-2314-B-002-010-MY3) in Taiwan. We thank the infants and their parents for participation in the study and the medical and nursing staff of the Neonatal Intensive Care Unit at National Taiwan University Hospital, MacKay Memorial Hospital, and Taipei City Hospital Branch for Women and Children for their assistance in patient recruitment and
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