Neurodevelopment Outcome

The primary objective of this clinical trail is to evaluate whether early supplementation of levothyroxine (L-T4) at a dosage of 8 ug/kg/d, initiated in the second week of life, improves physical growth and neurodevelopmental outcomes at 2 years of corrected age in Small for Gestational Age (SGA) infants with birth weights \< 1500g and TSH levels between 6 and 20 mIU/ml. Preterm infants in the intervention group will receive 8 ug/kg/d of L-T4, while the control group will receive no supplementation. Physical growth will be assessed through height, weight, and head circumference, while neurodevelopmental status will be evaluated using the Bayley-IV scales and cranial MRI imaging findings.

The extremely preterm outborn births (delivered in maternity units without on-site neonatal intensive care) are associated with lower survival and increased risk of severe neurodevelopmental impairment compared with inborn births (delivered in maternity units with on-site neonatal intensive care). This project aims to assess the effect of the neonatal transport team (NNT) antenatal versus postnatal positioning on outborn survival without major neurodevelopmental sequelae at two years of corrected age (CA). A national, multicenter, observational cohort will be established over a two-year period, including all outborn births between 23+0-28+6 weeks' gestation in mainland France for which a NNT is deployed and who are alive at the moment of arrival of the NNT. 627 infants born outborn and their families will be followed until the child reaches two years of corrected age. Study will examine quality of neonatal resuscitation, stability during transport, neonatal morbidity, parental mental health and quality of life, medico-economic outcomes for both families and the healthcare system and regional provision of care. If parents agree to participate after receiving appropriate information, hospital records will be used to collect maternal and neonatal characteristics as well as morbidity data. Telephone follow-up will be conducted one month after discharge and then every six months until 2 years of corrected age (CA). Neurodevelopment at 2 years of corrected age will be assessed using the ASQ-3, completed by the parents. Through a detailed understanding of the processes of resuscitation, stabilization and transport, our goal is to reduce unnecessary deaths and disability for children and families, including long-term economic costs. The recommendations for the care of outborn preterm infants and for the optimization of NNT resources will be developed.

The goal of this study is to learn about how to best carry out neurodevelopmental screening methods (tests to see if a young child can use support with brain development) in routine clinic visits in Botswana and Kenya among children age 16-24 months old. The main questions it aims to answer are: 1. when used in routine clinic visits by healthcare workers, how many children are able to get screened; 2. are the screening tools appropriate and how can they best be used; 3. how much time and money does it take to use the screening methods? The investigators will compare two screening methods chosen by healthcare workers at the beginning of the study. Children will undergo a brief test of their brain development to see if they need further evaluation and support. Caregivers will be asked to complete a short survey to see what they thought of the screening test. Healthcare workers will complete brief surveys and interviews to see what they thought of carrying out the screening tests and how use of the screening tests can be improved in their clinics.

Infants born with congenital defects may require major surgery in the neonatal period. These infants are at risk for neurodevelopmental impairments. Additionally, their parents are at higher risk for adverse mental health outcomes. Early relationships are essential to healthy growth and development in all children. Relationships between parents and infants born with a congenital defect are negatively impacted by separation due to hospitalization; parental and infant stress exposures; and alterations in infant behavior and parental mental health. Benefits of H-HOPE intervention on infant neurodevelopment outcomes have been observed in healthy and at-risk term and preterm infant populations but never evaluated in infants with congenital defects. The purpose of this study is to examine impact of the Hospital to Home: Optimizing Preterm Infant Environment (H-HOPE) intervention versus standard ICU care for infants born with a congenital defect requiring neonatal surgery, and their parents. The main questions to be answered include: 1. Does H-HOPE improve pre-feeding state and behavior, oral feeding progression, and growth in infants born with a congenital defect requiring neonatal surgery? 2. Does H-HOPE neurodevelopmental outcomes in infants born with a congenital defect requiring neonatal surgery? 3. Does H-HOPE improve parental mental health outcomes among parents of infants born with a congenital defect requiring neonatal surgery? 4. Does H-HOPE improve parent-infant interactions among infants born with a congenital defect requiring neonatal surgery and their parents? 5. Does H-HOPE improve neuroendocrine function among infants born with a congenital defect requiring neonatal surgery and their parents? 6. Do parents of infants born with congenital defects requiring surgery experience participating in the H-HOPE intervention positively? Results of this study may provide preliminary evidence supporting use of H-HOPE to positively impact short- and long-term outcomes for these infants and their parents.

This clinical trial aims to learn if MMS Plus improves infant health compared to standard MMS during pregnancy and the postnatal period in women living in peri-urban areas of Karachi, Pakistan. It will also evaluate how MMS Plus affects infant growth during the first 6 months of life. The main questions it aims to answer are: 1. Does MMS Plus during pregnancy reduce the risk of poor infant outcomes compared to standard MMS, as measured on a 5-point ordinal scale ranging from perinatal mortality to term birth with appropriate, small, or large-for-gestational-age infants? 2. Does postnatal MMS Plus improve infant length velocity at 6 months of age among exclusively breastfed infants compared to standard MMS and iron/folic acid (IFA) supplementation? Researchers will compare: 1. MMS Plus versus standard MMS during pregnancy (antenatal phase) 2. MMS Plus versus standard MMS versus IFA after birth (postnatal phase) Participants will: 1. Be randomly assigned to receive either MMS Plus or standard MMS during pregnancy 2. Be re-randomized after delivery to receive either MMS Plus, standard MMS, or IFA supplements during the postnatal period 3. Receive supplements under double-blind conditions 4. Be followed through childbirth and until the infant is 6 months of age 5. Attend regular clinic visits for health monitoring, infant assessments, and data collection. This phase III adaptive randomized controlled trial will occur in three peri-urban catchment areas of Karachi, Pakistan.

The American Academy of Pediatrics defines high-risk infants as those with preterm birth, special health care needs, family risk factors, and those at risk of early death. Factors such as premature birth, perinatal asphyxia, hypoxic-ischemic encephalopathy (HIE), periventricular leukomalacia (PVL), intraventricular hemorrhage (IVH), chronic lung disease, seizures, meningitis, hyperbilirubinemia, twin/triplet pregnancy, and intrauterine growth restriction are risk factors that can result in morbidity and mortality in infants. Regular neurological examinations and neuromotor tests are necessary for at-risk infants to identify developmental problems early and to initiate early intervention programs.In developing countries, regular follow-up and early rehabilitation of at-risk infants are not successfully implemented. 5,6 The lengthy test batteries and busy clinics are among the most significant reasons. Therefore, the development and dissemination of shorter, valid, and reliable tests is of great importance. The Hammersmith Neonatal Neurological Examination (HINE), one of the gold standard methods, consists of 26 items and takes 15-20 minutes to administer.Due to the number of items and the duration, it is not frequently used routinely. In response to this clinical need, the HINE short scale was developed in 2024.The aim of the study is to have a Turkish version of the Abstract-HINE test in Turkey and to study its validity and reliability in high-risk infants.