The H-HOPE behavioral intervention plus Kangaroo Mother Care increases mother-preterm infant responsivity in Malawi: a prospective cohort comparison

Preterm birth, defined as birth prior to 37 weeks gestational age, remains a major global public health concern with about 15 million preterm births occurring annually [1]. Complications of prematurity include difficulty regulating body temperature, breathing, and feeding and accounts for 35% of neonatal deaths [2]. Even when preterm neonates have no major neurosensory and motor impairments, they are at higher risk for developmental, behavioral, and socio-emotional problems [3‐8]. Prematurity also negatively affects parents; they experience increased stress, anxiety, and depressive symptoms, have lower parenting confidence, and less optimal parent-infant interaction. Collectively, this adversely impacts parent-infant interaction and infant growth and development [9‐12].

Malawi carries a high burden of preterm birth at 18%, well above the global rate of 11% [13‐16]. Complications of prematurity in Malawi account for 36% of neonatal deaths [17] and contribute substantially to high neonatal and infant mortality rates (26 and 56 per 1,000, respectively) [18]. Malawian mothers with premature babies express fears about survival and long-term health and development of their small and fragile infants [19‐21]. Additionally, prematurity is stigmatized because this is interpreted as a punishment from supernatural powers or as a consequence of having a disease, such as HIV [22].

One well-established intervention that that has been shown to reduce preterm infant morbidities and mortality is Kangaroo Mother Care (KMC), or near-constant skin-to-skin contact between the infant and mother [23]. In KMC, the infant is held inside the mother’s clothing with access to the breast for feeding. KMC has been shown to improve infant thermoregulation, nutrition, and organized sleep and reduced risk for morbidities and mortality [24‐26]. KMC is especially effective in low income countries that often lack equipment and services [24, 27]. When KMC was implemented in tertiary hospitals in Ghana, India, Malawi, Nigeria and Tanzania, the data showed that KMC was associated with significantly higher neonatal survival rates [26]. Since 2005, KMC has been the standard of care in Malawi [28]. However, mothers in Malawi practicing KMC still experience the high stress, anxiety and stigma associated with a preterm birth. KMC exacerbates this stress because health facility policies do not allow visitors on the KMC Unit. Therefore, mothers are alone with their infants while providing 24-h KMC without support [21]. An additional stigma is associated with KMC because in Malawi mothers are expected to carry babies on their backs and not on their chest [19]. Even though mothers are practicing KMC and in near-continuous contact with their infant, their fears and stressors lead to a reluctance to engage with the neonate [19, 20, 22, 29, 30].

Another well-established intervention that is beneficial to preterm infants is an early behavioral intervention that promotes development. Developmentally-based interventions have positive impacts on brain maturation, feeding, health and development, and parent-infant interaction [31‐33]. These benefits led the WHO to recommend early developmental interventions for preterm infants [34] and in the United States (US), the Physical Environment Exploratory Group endorsed these interventions as the standard of care [35]. However, early behavioral interventions that are developmentally-based have not yet been implemented to promote premature infant development in Malawi.

The only early behavioral intervention for preterm infants with both well-established efficacy and a standardized protocol is H-HOPE (Hospital to Home: Optimizing the Preterm Infant Environment) [36]. H-HOPE has both parent- and infant-focused components. The infant-focused component was developed first and is a multisensory intervention that provides auditory, tactile, visual, and vestibular stimulation. Originally called ATVV, the infant component is now called Massage + for easier recognition by parents. Because parents of preterm infants continued to experience high stress and anxiety, H-HOPE added a component for parents called Parents + , which uses participatory guidance to help parents to read, interpret and respond to preterm infant cues and provide Massage + for their infant. In a US randomized controlled trial, the full H-HOPE intervention, including both Parents + and Massage + , yielded significant positive intervention effects including infant alertness prior to feeding, feeding readiness behavior, efficiency of sucking, feeding progression, more rapid growth and development, and lower initial hospitalization costs at discharge [37‐45]. At 6-weeks CA, the H-HOPE cohort had increased mother-infant social interaction and responsivity and fewer illness visits at 6-weeks CA [37, 38, 46, 47]. Earlier studies of Massage + /ATVV alone also found improved parent-infant interaction including mother-infant mutual responsivity, maternal sensitivity toward the infant and social emotional growth fostering behaviors, infant responsivity toward the mother and infant clarity of cues [46, 48]. Increased mother-infant responsivity is also linked to infant language development [49].

Although the full H-HOPE intervention has not been tested in low- and middle-income countries (LMIC), several studies found that Massage + alone (ATVV) had positive impacts in these settings. In Colombia, first time breastfeeding mothers of full-term infants were allocated to a control or intervention group (ATVV provided for at least 2 weeks at home). In the intervention group, infant sucking ability and growth increased, maternal stress and postpartum depression decreased, and mother-infant responsivity at 6-weeks corrected age (CA) as measured by the Dyadic Mutuality Code (DMC) increased [50]. Similar results were reported from India [51]. As measured in the Infant Neurological International Battery (INFANIB) preterm infants in the ATVV arm had better motor development and tonal maturation than those who received routine care when they reached term age. However, these studies were not fully comparable to the US study as one did not use the DMC and the other did not study preterm infants.

Despite these benefits, an early behavioral intervention such as H-HOPE has never been tested for preterm infants and mothers in Malawi or any other African country. Because KMC is the standard of care for stable preterm infants in Malawi, any study would need to compare H-HOPE plus KMC with KMC only. KMC supports near constant mother-preterm infant skin-toskin contact, thermoregulation and constant access to breastfeeding, while H-HOPE fosters face-to-face positioning, mother-infant interaction and mutual engagement. Thus, the benefits of KMC and H-HOPE are complementary and preterm infants and parents should benefit from receiving both interventions. However, no prior studies have examined the impact of providing both H-HOPE and KMC, and only one study has directly compared the infant component of H-HOPE (Massage +) and KMC. That study, conducted in the US where mothers provided modified KMC with only intermittent skin-to-skin contact, found that premature infants receiving skin-to-skin contact exhibited significantly fewer social interactive behaviors than infants who received Massage + [52].

The purpose of this paper is to test the feasibility of offering H-HOPE + KMC and to compare mother-preterm infant dyads’ responsivity at 6-weeks CA for dyads receiving H-HOPE + KMC versus those receiving only KMC. As far as we know based on extensive review of published studies, this is the first study to examine the feasibility of providing H-HOPE for preterm infants in Africa, and the first study to examine the impact of providing H-HOPE along with KMC on mother-infant responsivity in any country.

In this study, at 6-weeks CA mother-preterm infant dyads who received both H-HOPE and KMC had substantially higher responsivity than those who received KMC only. This finding is congruent with the randomized controlled trial in the US where the H-HOPE intervention facilitated establishment of higher responsivity during play as well as more maternal social-emotional growth fostering behaviors and greater infant clarity of cues during feeding [46]. This is the only study that can be compared directly with the Malawi study because both studied preterm infants using the same measure of responsivity (DMC) and the same assessment time (6-weeks CA).

Notably, the effect size for our study in Malawi was very large (1.44), much larger that the effect size of 0.30 in the US study. The biggest difference in the responsivity between the two studies was the much higher proportion of KMC only dyads who had low responsivity scores. Reducing the number of mother-infant dyads with low responsivity at 6-weeks CA has high clinical relevance, as the developer of the DMC identified that low responsivity was an indicator for future mother-infant interaction problems that would warrant follow-up [57, 58].

The larger H-HOPE effect size in the Malawi study likely reflects major differences in the context of care and that KMC is Malawi’s standard of care. These two interventions together may enhance the mother-infant relationship more than H-HOPE alone. KMC provides mothers with constant physical contact with their infants, promoting closeness. H-HOPE teaches mothers to read, interpret, and respond to their infant’s cues and provides opportunities for mother-infant social interaction, including eye-to-eye contact and vocalizations during Massage +.

In Malawi a much larger proportion of dyads had low responsivity compared to the US study. Although providing KMC 24 h a day is good for the premature infant, the lack of engagement with relatives and friends is difficult, stressful, and isolating for the mothers [21]. The stress mothers experience when providing KMC in the hospital may be a major factor that slows the development of mother-infant responsivity. When mother-infant dyads experience H-HOPE this may foster optimal development of mother-infant responsivity.

Vaginal delivery (vs. Caesarean section) was the only other factor that predicted a higher mother-infant responsivity. Possible reasons for this relationship include the reasons for this type of delivery, such as preeclampsia or hemorrhage [63], inadequate pain relief, fatigue and difficulty in moving about, that could compromise mothers’ capability to fully engage with their infants. However, given that only 10 mothers in our sample had a Caesarean Section (five in each study condition), this pattern needs to be examined more closely in future studies.

Although individual level randomization is the gold standard, this design is not possible given that there are groups of mother-infant dyads in the KMC unit. Only 65% mothers returned to the hospital at 6-weeks CA, when responsivity was assessed. Returning to the hospital probably required more time and/or greater expense than a visit to the local clinic where mothers are usually referred. We extended recruitment to obtain a final sample with adequate power, but we cannot rule out the possibility that mothers who returned differed from those who did not in ways that were not measured. Finally, most mothers did not receive a prenatal ultrasound, so gestational age in the medical record was estimated by recall of last menstrual period (LMP) and fundal height assessment. However, gestational assessment by LMP and fundal height is not very reliable [64‐66]. To mitigate this limitation, when no ultrasound was available, we used the modified Ballard Index [55] to determine a more accurate gestational age.

This study demonstrated that H-HOPE can be provided in Malawi and has a high impact on the development of early mother-infant responsivity, fostering positive parent-infant relationships. H-HOPE is complementary to KMC, which is already the standard of care for preterm infants in Malawi. Incorporating H-HOPE along with KMC for mother-preterm infant dyads as the standard of care can support early parent-infant responsivity, infant feeding, and development. Changing clinical practice to include H-HOPE has the potential to dramatically reduce the number of mother-infant dyads with low responsivity. Improving early mother-preterm infant responsivity can avert the need for later follow-up, which is relatively unavailable in Malawi as well as many other low-resource countries.

Introducing H-HOPE as part of the standard of care for preterm infants would offer substantial benefits for preterm infants and their mothers, supporting early infant development and strengthening the mother-infant relationship that is crucial for infants to thrive. However, in this study, H-HOPE was offered by a nurse research assistant. Having nurses provide H-HOPE is probably not feasible for widespread introduction of H-HOPE due to the nursing shortage in Malawi. A patient attendant is always present in the KMC unit, and the patient attendants expressed high interest in the H-HOPE program. If patient attendants can be trained to provide H-HOPE with fidelity, introducing H-HOPE would be highly cost-effective. H-HOPE offers a critical early behavioral intervention to support preterm infants and their mothers. Offering H-HOPE as the standard of care complementary to KMC can contribute to the achievement of the WHO’s Sustainable Development Goal Number 3, to ensure optimal health and promote mother and infant well-being [67].

Corrected Age (CA): chronological age of infant reduced by the number of weeks born before 40 weeks of gestation