Nutritional management of growth faltering in infants aged under six months in Asia and Africa - Study protocol for an individually randomized trial

Growth is important for term, preterm and low birth weight infants. The first six months of life are​ a critical period. The inability to achieve growth (slower weight gain than expected) is known as “growth faltering”. It is associated with a high risk of mortality, morbidity and poor neurodevelopmental outcomes. 

The most important mediation to prevent and manage growth faltering is to encourage and support exclusive breastfeeding, including intensive lactation management when required, and care for maternal health and nutrition. 

In addition, there needs to be rigorous evaluation of the role of nutritional supplementation (e.g. the addition of a standard infant formula milk) earlier than 6 months for infants who do not respond to intensive lactation management and treatment of medical problems. ​

Team: Dr. Fyezah Jehan (Principal Investigator, Chair, Paediatrics), Dr. M. Imran Nisar (Co-PI), Dr. Zohra Kurji (Co-PI), Dr. Sama Rattani (Co-PI and IBCLC), Dr. Rubina Barolia (Co-PI), Saleema Gulzar (Co-PI) Usma Mehmood and Dr. Aysha Arif. ​

Sponsor: WHO, Bill & Melinda Gates Foundation, Global Innovation Fund 

​Site: Two peri-urban sites, Bhains Colony and Ali Akber Shah Goth, located in Bin Qasim and Korangi town, respectively in Sindh, Pakistan

Aims: This planned randomized trial aims to determine the effect of nutritional supplementation along with intensive breastfeeding and compare it with only intensive breastfeeding support, on mortality, morbidity and growth in infants aged 0-6 months with growth faltering in low resource settings. 

Methods: The study aims to prevent mortality or adverse growth outcomes at 6 months of age, that are reported to be related to reduced early childhood development in the first 2 years of life. 

The study will inspect for and apply interventions to moderate early adverse growth patterns and those predictive of mortality. Antenatal messaging will be provided to all pregnant women in the study catchment areas to prepare for birth and breastfeeding initiation. Facility based health staff and community-based peer counsellors will provide quick and continued repeated support for breastfeeding and problems while breastfeeding to all mothers. 

Birth weight will be assessed at 72 hours and will be randomized into control and intervention arms by an independent statistician through a server-based web, assigned to study groups between 7 to 14 days. 

Data will be collected from the infant on feeding practice and health status. Infants born with low birth weight (preterm or term) will receive additional support and more frequent review. 

Infant weight measurements will be repeated to guide the level of breastfeeding counselling to mothers. Focused and intensified skilled support will be provided to mothers whose infants are not gaining adequate weight. 

Breast feeding promotion and support activities have been explicitly designed to achieve WHO proposals and principles. Understanding the health impacts of WHO standards for breastfeeding support has enormous public health importance and will clarify when and where nutritional milk supplements are really needed.

Impact​: This study will reinforce the importance of exclusive breast feeding to prevent the harmful effects of reduced growth of infants (birth to 6 months of age). The intensive education and counselling of pregnant women and infant mothers will reiterate the importance of providing the growing child with breastfeed as the most important source of nutrition, also it will provide a supportive environment to enable breastfeeding, its early and effective initiation as well as maintenance. 

This study will also identify those infants who are experiencing slow growth at the time of the study and cater to their specific need in terms of providing their mothers with the necessary support to optimize their breastfeed for the baby and/or facilitate supplementation by infant formula milk. Engaging the community will be accomplished by explaining the study to the local village and town leaders and accommodating their input to ensure effective information sharing and dissemination. Mothers and families will be encouraged to attend their own existing health facilities.