COMBO

Enrollment numbers 

Enrollment Totals

• Total dyads enrolled across COMBO and ESPI COMBO: 1,915
  • Dyads enrolled in COMBO: 1,452
    • Dyads enrolled prenatally: 667
    • Dyads enrolled postnatally: 785
  • Dyads enrolled in ESPI-COMBO: 463
    • Dyads enrolled from University of Alabama-Birmingham: 87
    • Dyads enrolled from University of Utah: 243
    • Dyads enrolled from CUIMC: 133

Surveys Completed

• Prenatal: 665
• Postnatal: 6,334

Follow-up visits

• 4 month video: 542
• 6/9 month video (mother): 545
• 6/9 month video (baby): 534
• 12 month video: 16
• 24 month video: 429
• 24 month freeplay video: 402
• 36 month: 637
• QMR: 45
• fMRI: 47 (mother+infant)
• Mother interviews: 64
• Socialization Goals: 85

Olfaction and Biospecimens

• Smell test: 493
• Maternal blood: 70
• Cord blood: 61
• Placenta: 75

Last updated: 12/05/2024

About COMBO 

COMBO is the only longitudinal mother-child cohort that combines: 

• maternal mental health 
• ongoing child developmental data 
• Covid infection status during pregnancy and comprehensive evaluations of multiple components of the child’s early relationships (including bonding, attachment, maternal sensitivity, and dyadic emotional synchrony) to uncover how each aspect maps onto future outcomes across multiple domains of development, throughout the lifespan of the child. 

Distinct in this way from initiatives such as ECHO, ABCD, HBCD, and RECOVER, the COMBO cohort is singularly poised to accelerate advancements in generational health outcomes, across medical fields, with a particular focus on how early relationships shape life-course health and wellbeing for families. 

With over 2,000 mother-baby pairs (“dyads”) enrolled in its first 5 years (and additional caregivers soon to be included in the national expansion), this study has grown far beyond Covid and will continue to follow children born during the pandemic through adulthood. 

A world-leading study of mothers and babies 

A collaborative effort of over 200 inter-departmental physicians, scientists, staff, and students from over 20 institutions across the U.S., COMBO has developed some of the most sophisticated protocols for the qualitative and quantitative evaluation of ERH (including through the dyadic lens of emotional connection). 

This consortium-style model, which emerged out of Columbia’s award-winning Maternal Child Research Operations (MaCRO) Consortium team science model, enables highly skilled researchers across a broad range of expertise to compile and analyze unprecedented data on both parents and children, at key developmental time points, from the prenatal period throughout the child’s life course. 

Thanks to this model, COMBO’s collaborators are often the first to publish important findings about children born since 2020 and their families — to date, they have published over 25 foundational peer-reviewed manuscripts together and influenced national and global policies. 

Through the intersecting efforts of these many specialties — including public health, implementation science, medicine, neurology, nursing, pediatrics, OB/GYN, child development, psychology, neuroscience, engineering, computational science, psychiatry, and more — COMBO has created, and continues to build upon, an irreplaceable foundational data set on families who demonstrated resilience in an unprecedented time. 

Data from cohorts born during previous pandemics have taught us to be vigilant about later increases in diagnoses such as asthma, metabolic disturbances, autism spectrum disorder, mood disorders, and schizophrenia. As this generation ages into various risk windows, COMBO’s uniquely rich data set is critical to investigating potential adverse health consequences and primary prevention opportunities. 

COMBO’s first core mission is to continue following its unique cohort through adulthood, to understand this generation’s developmental needs and leverage that data into opportunities for both early intervention and primary prevention. 

As COMBO innovated interdisciplinary and remote protocols for studying ERH, it paved the way for a second core mission: to grow this cohort into the first national study focusing specifically on ERH. 

By attaching key, real-time, relational research to unprecedented social disruption, COMBO offers a once-in-a-generation opportunity: a truly comprehensive, longitudinal look at early childhood relationships as mediators of lifelong outcomes, complete with the context that makes that data actionable, faster. 

The Story of COMBO 

In March of 2020, Columbia was one of the hardest-hit hospitals in the country. There was no way to know how the pandemic would impact the generation of children about to be born. As a frontline physician in the Newborn Medicine Unit, center director Dr. Dumitriu saw firsthand the fear, stress, and grief new families were facing from uncertainty and separation.

Recognizing an unprecedented need to rapidly gather information about the effects on families, Dr. Dumitriu immediately pushed for resources and launched an initiative that became one of the first to find answers, globally. 

As an early relational health researcher from the start, Dr. Dumitriu’s unique perspective at this time helped lead reunite mothers and babies across the country, and around the world: 

When COMBO published the revolutionary finding that viral transmission from mother to baby is extremely rare (during pregnancy, birth, or breastfeeding), hospitals were able to end their precautionary policies of separating mothers and infants. The postpartum period is critical for maternal health, infant development, and the mom-baby relationship; this groundbreaking finding became the first of many from COMBO to directly alleviate families’ and clinicians’ stress, fear, and uncertainty. 

Their continued commitment to a relational focus in this research ultimately led to COMBO’s expansion into the first nationwide study to focus specifically on ERH and its lifelong outcomes. 

Key Findings 

For a parent-focused resource outlining some of our biggest findings in the first 5 years of COMBO, click here. 

So far, COMBO’s results are reassuring: 

• There does not seem to be any significant developmental effect on babies whose moms had Covid during pregnancy. These babies: ○ are developing just as well as other babies in learning & understanding, language, and movement (aspects of brain development) through the first year of life 
• Are not at greater risk for hearing loss (as babies or as toddlers) 
• Have similar temperaments (at 6 months old) as babies who were not exposed during pregnancy, including being able to regulate their own emotions and behavior at an age-appropriate level 
• Mothers have an extremely low risk (~2%) of transmitting Covid to their babies during pregnancy, after birth, or while breastfeeding. ○ This finding was a groundbreaking step in confirming the safety of mothers and infants “rooming-in” together postpartum and breastfeeding, both of which are known to be highly beneficial for mother and child. 
• Whereas the start of the pandemic saw newborns separated from their mothers for fear of transmitting the virus, this research influenced a turnaround in hospital policy at the national and global level. 
• Because of this policy reform, Dr. Dumitriu was asked to collaborate on a Dear Colleagues Letter to senate leaders ■ The letter laid out scientific reasons for funding to be directed to unfunded research areas including child development and mental health 
• This letter ultimately helped infuse $1.5 billion into the research initiative that became the RECOVER Initiative.

Key findings for children born 2020-2022 

While prenatal exposure to the Covid-19 virus does not seem to be impacting children’s development, COMBO is seeing some differences in neurodevelopmental outcomes for babies born from 2020-2022, whether or not their mothers had Covid in pregnancy, making stress from social disruption a key area of focus: 

• Compared to babies born before the pandemic, babies born during the pandemic are slower to develop certain developmental skills (at 6 months old), such as fine & gross motor skills and social skills ○ (This may be because the first trimester of pregnancy is a critical time point when stress can actually get embedded into fetal development). 
• These seminal findings contributed to a global action plan to optimize brain health across the life course and establish brain health as a pressing global priority. \
• The JAMA Pediatrics publication of these findings is in the top 5% of all research outputs scored by Altmetric and has been cited in over 316 news stories from 223 outlets around the world, including PLOS Medicine, the International Journal of Infectious Diseases, the Washington Post, Scientific American, Science, Nature, NBC News, CNN , Today, Nouvelles du Monde, Espanol News, and the Times of India. 
• As quoted in the New York Times, Dr. Dumitriu asserts, “It is absolutely possible for these children to catch up, if we catch things early. There is nothing deterministic about a brain at six months.” To identify early opportunities for intervention, continuing to follow these children is essential. 
• Children born during the pandemic are not more likely to screen positive for autism at 18 months — whether or not their moms had Covid during pregnancy — compared to children born in the two years before the pandemic.
• Dr. Dumitriu says: “It’s important to note that we're not looking at autism diagnosis here. We're looking at autism risk, based on parent report. It’s too early to have definitive diagnostic numbers. But this screen is predictive, and it’s not showing that prenatal exposure to Covid or the pandemic increases the likelihood for autism.” 

Key findings for mothers who gave birth in 2020 

• While prenatal Covid exposure does not impact a baby’s temperament, a mom’s stress levels can: ○ Mothers experienced pandemic-related stress whether or not they had Covid during pregnancy 
• As moms’ perceived stress levels increased during the first 4 months postpartum, their babies had a harder time with emotions & behavior, and tuning into their moms (at 6 months old) 
• Pregnant and postpartum moms experienced disruptions in their medical care in the first year of the pandemic (such as canceled prenatal visits) that impacted their mental health: Depression and anxiety symptoms were exacerbated in mothers who reported more changes in their perinatal care, and especially in moms who were separated from their baby after birth.
• When infants didn’t sleep well, it lowered their mothers’ quality of sleep.
• Both pregnant and postpartum mothers slept better & had better energy levels when they used active coping methods (such as social support and self-care) versus passive coping methods (such as screen time and social media use).

Upcoming protocols for this cohort 

• While COMBO continues to enroll pregnant mothers, the original COMBO cohort children are turning 4 & 5 this year. The data so far show that this generation may be slower to reach some developmental milestones, with ongoing potential for future neurodevelopmental findings. 
• For example, while these children are not screening positive for higher risk of autism, Dr. Dumitriu says that “doesn't mean we might not see jumps in other areas. The risk of various neurodevelopmental conditions changes based on different insults, so there's still a risk that we might see increases in ADHD, depression, anxiety, and (later on) schizophrenia. Continued long-term monitoring is important for primary prevention and early intervention.” 
• Given this, and with school readiness on the horizon for this cohort, COMBO’s study protocols are transitioning more fully into an ERH focus, with key developmental assessments, including: 
  • Social & emotional skills 
  • Fine & gross motor skills 
  • Cognition and language 
  • Memory 
  • Behavioral regulation 
  • Emotional & biobehavioral synchrony